ClinicalTrials.gg
CompletedNCT01293799PEPSUpdated Dec 16, 2025Results posted

Prevention of Peritonitis in Peritoneal Dialysis

An interventional study of Retraining in Kidney Failure, Chronic, Peritoneal Dialysis-associated Peritonitis and Dialysis Capd Infection, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Sahlgrenska University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
713
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

BACKGROUND: Peritonitis remains a significant problem in peritoneal dialysis (PD). It is the leading cause of technique failure, and contributes to mortality. The incidence is highest during the first year of treatment. Non-compliance with the PD protocol is shown to be an important risk factor for peritonitis. Reinforcement of knowledge and ability to perform PD therefore appears to be a possible way to reduce the incidence of peritonitis. This will be studied in The PEritonitis Prevention Study (PEPS).

METHODS: The objective of this randomized, multi-centre investigation, which will include 750 new PD patients who can perform (PD) without assistance, is to evaluate if regular retraining can reduce the incidence of peritonitis, the technique-failure rate, and the hospitalisation days due to peritonitis compared with regular follow-up regimen. Patients in the intervention group will be tested by a PD-technique test and a questionnaire at regular intervals after PD-start and after every peritonitis episode with focus on infection prophylaxis. If needed, they will be retrained. The control group will be treated according to the routine of the center.

The study is ongoing in Denmark, Norway, Sweden, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom (UK). The study will go on for 6 years.

Read the detailed description

BACKGROUND See above.

AIMS The primary aim of this trial is to study if regular follow-up of PD patients with testing of their theoretical and practical knowledge (hereafter called "new type of follow-up") can reduce the time to first peritonitis episode. Secondary aims were to study if the new type of follow-up could reduce the incidence of peritonitis, the technique failure rate related to peritonitis, and the time of hospitalization related to peritonitis compared to a routine regimen. For specific aims, see "Outcome measures" below. A further aim was to study risk factors for peritonitis.

PATIENTS AND METHODS The study is a randomized, multi-centre investigation intending to enclose 750 new PD patients in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom. Inclusion was finished on December 31, 2014. The study will go on until the last included patient has taken part of the study for one year. The study will thus be terminated on December 31, 2015.

The study includes a retraining group and a control group. The intervention in the retraining group consists of regular testing of theoretical and practical knowledge regarding PD with focus on infection prophylaxis including retraining if needed until the test goals are reached. The control group will be treated according to the routines of the center. Peritonitis is defined according to International Society for Peritoneal Dialysis (SPD) guidelines (Peritoneal Dialysis International 2005;25:107-131)

The baseline PD training will be the same at all participating centres and follow international recommendations. In addition, fluorescent alcohol and a UV lamp will be used to control the result of hand disinfection in all patients once during the initial PD training. Thereafter this method will only be used in the retraining group..

In the retraining group, the knowledge from the basal training will be tested at 1, 3, 6, and 12 months after PD start, every sixth month thereafter, and after every episode of peritonitis. Such testing will also be performed at restart of PD and includes two types of tests:

  1. The patient will fill in a questionnaire with theoretical and practical questions with focus on infection and infection prophylaxis during PD treatment. Goal: At least 80% of the questions should be correct. If the goal is not reached, further training will be given until the goal is reached.
  2. The patient will perform a practical test including hand disinfection, PD exchange technique, and exit-site care. Hand disinfection skills will be controlled with the help of fluorescent alcohol and a UV lamp. Goal: All steps of the practical test should be correctly performed. If not, further training will be given until the goal is reached.
02

Conditions studied

  • Kidney Failure, Chronic
  • Peritoneal Dialysis-associated Peritonitis
  • Dialysis Capd Infection

Keywords

  • Randomized
  • Peritoneal dialysis
  • Peritonitis
  • Primary prevention
  • Quality control
  • Self care
  • Kidney failure, chronic
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's enrollment of 713 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient is able to perform PD without assistance
  • Age 18 years old or more

Exclusion criteria

Exclusion Criteria:

  • Previous PD-treatment less than 2 years ago
  • Peritonitis before inclusion
  • Active
  • Participation in other studies during the study period which may affect outcome of the present study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
713 participants (actual)

Study arms

  • Experimental
    The retraining group

    The intervention in the retraining group consists of regular tests of the patients´ theoretical and practical skills regarding peritoneal dialysis. The test goals should be passed. If not, retraining will be given if needed til the goals are reached. The peritonitis rate in this group will be compared with that of the control group.

    Behavioral: Retraining

  • No intervention
    Control group

    Patients randomised to the control group will be treated according to the routines of the clinic.

Interventions

  • BehavioralRetraining

    Testing of the patients´ knowledge and retraining will be given if needed

06

What researchers measure

Primary outcomes

  1. Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group

    Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.

Secondary outcomes

  1. Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group

    The incidence of a first peritonitis episode is expressed as the mean rate of a first peritonitis per patient year (event rate) with 95% confidence interval.

    Time frame: The participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. The time in study was calculated for each participant

  2. Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group

    The incidence of peritonitis episodes is expressed as the mean rate of peritonitis per patient year (event rate) with 95% confidence interval.

    Time frame: The participants were followed from 1 month after PD start (time of randomization) up to 36 months after start of peritoneal dialysis, The time (days) of participation in the study was calculated for each participant.

Other outcomes

  1. Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group

    The association of baseline variables (at PD start) was studied in the whole study group. Age was recorded at baseline. Data were collected at baseline except for medication, PD modality (CAPD/APD, continuous ambulatory PD/automatic PD), number of PD bags and volume of dialysis fluid used per day, and if help with exit-site care was needed. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  2. Analysis of "Gender" in Association With Time to First Peritonitis Episode in the Whole Study Group

    Outcome data for the baseline variable "Gender" is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  3. Analysis of "Body Weight" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for body weight at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  4. Analysis of "Body Mass Index" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for body mass index at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  5. Analysis of "Diabetic Nephropathy" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for the baseline variable "Diabetic nephropathy" as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  6. Analysis of "Glomerulonephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for the baseline variable "Glomerulonephritis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  7. Analysis of "Tubulointerstitial Nephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for the baseline variable "Tubulointerstitial nephritis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  8. Analysis of "Polycystic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for the baseline variable "Polycystic kidney disease" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  9. Analysis of "Ischemic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for the baseline variable "Ischemic kidney disease" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  10. Analysis of "Nephrosclerosis/Hypertension" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for the baseline variable "Nephrosclerosis/hypertension" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  11. Analysis of "Other Diagnosis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for the baseline variable "Other diagnosis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  12. Analysis of "Unknown Primary Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Outcome data for the baseline variable "Unknown primary cause of kidney failure" as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  13. Analysis of "Comorbidity" (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Comorbidity" in association with time to first peritonitis episode is presented. The Stoke grading system of cardiovascular comorbidity was used to reflect the comorbid burden. Comorbidity was graded "0" when absent, "1" when 1 or 2, and "2" when 3 or more conditions were present. The association of baseline variables (at PD start) or time-updated variables with time to first was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  14. Analysis of "Ischemic Heart Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Ischemic heart disease" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  15. Analysis of "Peripheral Vascular Disease or Stroke" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Peripheral vascular disease or stroke" (yes vs. no) in association with time to first peritonitis episode is presented. Peripheral vascular disease or stroke"" includes distal aortic, renovascular, and cerebrovascular disease as well as symptomatic disease in these vascular territories e.g. cerebrovascular accident, claudication, amputation or significant stenosis \>50% on vascular imaging or Doppler ultrasound. The association of baseline variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  16. Analysis of "Left Ventricular Dysfunction" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Left ventricular dysfunction" (yes vs. no) in association with time to first peritonitis episode is presented. Left ventricular dysfunction includes clinical evidence of pulmonary oedema not attributable to errors in fluid balance or moderate to severe left ventricular dysfunction on echocardiography, or clinical signs of symptomatic moderate to severe heart failure. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  17. Analysis of "Diabetes Mellitus as Comorbidity" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Diabetes mellitus as comorbidity" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  18. Analysis of "System Collagen Vascular Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "System collagen vascular disease" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  19. Analysis of "Other Significant Pathology" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Other significant pathology" (yes vs. no) in association with time to first peritonitis episode is presented. Other significant pathology includes diseases like severe chronic obstructive airway disease, liver cirrhosis, psychotic illness, and severe osteoarthritis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  20. Analysis of "Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Diabetes mellitus as comorbidity or main cause of kidney failure" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  21. Analysis of "Previous Kidney Replacement Therapy" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Previous kidney replacement therapy" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  22. Analysis of "Functional Status (Karnofsky Score)" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Functional status (Karnofsky score)" in association with time to first peritonitis episode in the whole study group is presented. Functional status was estimated using the Karnofsky Performance Scale with scores from 100 (Normal, no complains, no evidence of disease) to 0 (dead). 90 = Able to carry on normal activity, minor signs or symptoms of disease. 80 = Normal activity with effort, some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or do active work. 60 = Requires occasional assistance, but able to to care for most of her/his needs. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  23. Analysis of the Social Factor "Visual Impairment" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline variable "Visual impairment" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  24. Analysis of the Social Factor "Impaired Hand Function" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline social factor "Impaired hand function" (yes vs. no) in association with time to first peritonitis episode is presented. The impairment of hand function was unspecified. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  25. Analysis of the Social Factor "Working Full or Part Time" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline social factor "Working full or part time" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  26. Analysis of the Social Factor "Retired" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline social factor "Retired" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  27. Analysis of the Social Factor "Living Alone" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline social factor "Living alone" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  28. Analysis of the Social Factor "Need for Translation/Interpreter" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline social factor "Working full or part time" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  29. Analysis of the Social Factor "Current Smoking" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline social factor "Current smoking" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  30. Analysis of the Biochemical Characteristic "Serum Creatinine" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline biological characteristic Serum creatinine (micromol/L) in association with time to first peritonitis episode is presented. Serum creatinine was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  31. Analysis of the Biochemical Characteristic "Serum Urea" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline biological characteristic Serum urea (mmol/L) in association with time to first peritonitis episode is presented. Serum urea was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  32. Analysis of the Biochemical Characteristic "Serum Albumin" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline biological characteristic" Serum albumin" (g/L) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  33. Analysis of the Biochemical Characteristic "Serum Albumin (< 35 g/L vs. 35 g/L or More)" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline biological characteristic "Serum albumin" (\< 35 g/L vs. 35 g/L or more) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  34. Analysis of the Biochemical Characteristic "Haemoglobin" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of the baseline biological characteristic "Serum haemoglobin" (mmol/L) in association with time to first peritonitis episode is presented. Serum haemoglobin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  35. Analysis of the Use of a "Corticosteroid Drug" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The analysis of the use of a "Corticosteroid drug" (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Time-dependent univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on corticosteroid treatment at baseline is presented below.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  36. Analysis of "Cytotoxic Treatment" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    Analysis of "Cytotoxic treatment" (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the time-dependent univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on cytotoxic treatment at baseline is presented below.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  37. Analysis of "Type of Start of Peritoneal Dialysis" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of "Type of start of peritoneal dialysis" in association with time to first peritonitis episode is presented. The type of start of peritoneal dialysis could be either planned or acute. The association of "Type of start of peritoneal dialysis" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  38. Analysis of "The Use of Antibiotics Prior to PD Catheter Insertion" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The statistical analysis of "The use of antibiotics prior to PD catheter insertion" (yes vs. no) in association with time to first peritonitis episode is presented. Antibiotics prior to PD catheter insertion may be given to prevent infection. The association of "The use of antibiotics prior to PD catheter insertion" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants who used antibiotics prior to PD catheter insertion is presented below.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  39. Analysis of "the Type of PD Catheter Used" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    PD catheters could be either be straight or coiled. The statistical analysis of "the type of PD catheter used" (straight vs. coiled) in association with time to first peritonitis episode is presented. The association of "the type of PD catheter used" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  40. Analysis of "PD Modality (CAPD/APD)" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    "PD modality (CAPD/APD)" in Association With Time to First Peritonitis Episode in the whole study group was studied. A participant either used CAPD (Continuous Ambulatory Peritoneal Dialysis) or APD (Automated Peritoneal Dialysis) but may change the PD modality during the study. This variable may vary with time and is thus time-dependent. The time-dependent data was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data was included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The c

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  41. Analysis of "Number of PD Bags Used/24h" in Association With of Time to First Peritonitis Episode in the Whole Study Group.

    The association of the "Number of PD bags used/24h" and Time to First Peritonitis Episode was studied. The number of PD bags used/24h many vary with time, as this variable is thus time-dependent. Data from PD start is presented below. As described in "Outcome measure 39", data was collected at each study visit. We recorded the number of bags connected to the PD catheter/24h in CAPD patients and in APD patients we recorded the number of bags connected to the tubing set/24h adding the daily number of bags connected to the PD catheter if additional manual daytime exchanges were used. The time-dependent data was included in a time-dependent univariable Cox regression to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  42. Analysis of "The Volume of Dialysis Fluid Used/24h" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The association of "The Volume of Dialysis Fluid used/24h" with the time to first peritonitis episode is analysed in the whole study group. The volume of dialysis fluid used per 24h can vary with time and is thus time-dependent. The dialysis fluid volume/24h used at PD start is reported below. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data were included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  43. Analysis of "Need of Help With Exit-site Care" in Association With Time to First Peritonitis Episode in the Whole Study Group.

    The exit site is the point where the PD catheter emerges from the skin of the abdomen. The number of "participants who needed of help with exit-site care at PD start is reported below. The need of this help may vary with time. This variable is thus time-dependent. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The data were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

  44. Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode

    Analysis of the association of the Study group (retraining group vs. control group) with time to first peritonitis episode is presented. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

    Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.

07

Results

Posted Dec 16, 2025
Limitations and caveats
The limitations of the study mainly concerns its low power. The power calculation was based on a discontinuation rate of 30% of the participants after one year, However, 40% of the participants had left the study at that time. The power was also weakened by the fact that the recruitment to the study was slower than anticipated, and the final number of randomized participants was only 89% (671 0f 750) of the target, despite the fact that the inclusion time was extended from 2 years to 5 years.

Participant flow

Recruitment started on January 18th, 2010 and ended on December 31st, 2014. The recruitment time was prolonged from planned two years to five years. Of the 713 initially included subjects, only 671 met the inclusion criteria. Of the 671 randomized subjects, 331 were assigned to the Control group and 340 to the Follow-up group.

Participant flow — Overall Study
MilestoneThe Retraining GroupControl Group
Started340331
First peritonitis episode102121
Completed6786
Not completed273245
Withdrew: Kidney transplantation10996
Withdrew: Transfer to hemodialysis7090
Withdrew: Death2729
Withdrew: Transfer to assisted pd2418
Withdrew: Withdrawal by subject260
Withdrew: Investigator decision52
Withdrew: Kidney function improved67
Withdrew: Other causes63

Outcome measures

PrimaryTime to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group

Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.
Reported as:
Median · Days to first peritonitis episode
Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group
Days to first peritonitis episodeThe Retraining GroupControl Group
Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group381 (154 to 555)368 (161 to 617)
Statistical analysis
  • The Retraining Group vs Control Group · Log Rank · p = 0.51 (The threshold for statistical significance was P = 0.05) · Hazard ratio (hr): 0.92 · 95% CI 0.71 to 1.19Hazard ratio was the ratio between the hazard rate of the retraining group (nominator) and the hazard rate of the control group (denominator).
SecondaryIncidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group

The incidence of a first peritonitis episode is expressed as the mean rate of a first peritonitis per patient year (event rate) with 95% confidence interval.

Time frame:
The participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. The time in study was calculated for each participant
Reported as:
Mean · Peritonitis events per patient-year
Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group
Peritonitis events per patient-yearThe Retraining GroupControl Group
Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group0.29 (0.23 to 0.35)0.31 (0.26 to 0.37)
Statistical analysis
  • The Retraining Group vs Control Group · Generalized linear methods · p = 0.51 (P-value \<0.05 is regarded as significant.) · Risk ratio (rr): 0.92 · 95% CI 0.70 to 1.19In calculation of the Risk Ratio, data for the Retraining group represents the nominator and data for the Control group represents the denominator.
SecondaryIncidence of All Peritonitis Episodes in the Control Group and the Retraining Group

The incidence of peritonitis episodes is expressed as the mean rate of peritonitis per patient year (event rate) with 95% confidence interval.

Time frame:
The participants were followed from 1 month after PD start (time of randomization) up to 36 months after start of peritoneal dialysis, The time (days) of participation in the study was calculated for each participant.
Reported as:
Mean · Peritonitis event rate per patient year
Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group
Peritonitis event rate per patient yearControl GroupThe Retraining Group
Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group0.36 (0.31 to 0.41)0.33 (0.28 to 0.39)
Statistical analysis
  • Control Group vs The Retraining Group · Generalized linear methods · p = 0.54 (P-value \<0.05 was significant.) · Risk ratio (rr): 0.93 · 95% CI 0.75 to 1.16In the calculation of the relative risk, data for the retraining group represents the nominator and data for the control group represents the denominator.
Other pre-specifiedAnalysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group

The association of baseline variables (at PD start) was studied in the whole study group. Age was recorded at baseline. Data were collected at baseline except for medication, PD modality (CAPD/APD, continuous ambulatory PD/automatic PD), number of PD bags and volume of dialysis fluid used per day, and if help with exit-site care was needed. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Median · Age, years (See statistical analysis 1)
Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group
Age, years (See statistical analysis 1)The Retraining GroupThe Control GroupThe Whole Study Group
Analysis of Age in Association With Time to First Peritonitis Episode in the Whole Study Group64 (19 to 87)62 (19 to 88)62 (19 to 88)
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.0052 (Unit of measure: Age (hazard ratio per 10 years). The threshold for statistical significance was P = 0.05) · Hazard ratio (hr): 1.15 · 95% CI 1.04 to 1.27The association of a age (HR per 10 years) and time to first peritonitis episode by univariable Cox regression.
  • The Whole Study Group · Regression, Cox · p = 0.0041 (Unit of measure: Age (hazard ratio per 10 years) and time to first peritonitis episode by multivariable Cox regression. The threshold for statistical significance was P = 005.) · Hazard ratio (hr): 1.16 · 95% CI 1.05 to 1.29Multivariable Cox regression
Other pre-specifiedAnalysis of "Gender" in Association With Time to First Peritonitis Episode in the Whole Study Group

Outcome data for the baseline variable "Gender" is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Gender" in Association With Time to First Peritonitis Episode in the Whole Study Group
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Male participants229217446
Female participants111114225
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.13 (Unit of measure: Gender (male vs. female). P \<0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.25 · 95% CI 0.93 to 1.66Univariable Cox regression was used.
Other pre-specifiedAnalysis of "Body Weight" in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for body weight at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Mean · Kg
Analysis of "Body Weight" in Association With Time to First Peritonitis Episode in the Whole Study Group.
KgThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Body Weight" in Association With Time to First Peritonitis Episode in the Whole Study Group.77 ± 1579 ± 1678 ± 15
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.0068 (Unit of measure: Body weight (hazard ratio per 10 kg). The threshold for statistical significance was P = 0.05.) · Hazard ratio (hr): 1.12 · 95% CI 1.03 to 1.21Univariable Cox regression was used.
  • The Whole Study Group · Regression, Cox · p = 0.03 (Unit of measure: Body weight (hazard ratio per 10 kg). P \< 0.05 is considered significant.) · Hazard ratio (hr): 1.10 · 95% CI 1.01 to 1.19Multivariable Cox regression
Other pre-specifiedAnalysis of "Body Mass Index" in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for body mass index at PD start is presented. The association of baseline variables (at PD start) or time-updated variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Mean · Kg/m2
Analysis of "Body Mass Index" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Kg/m2The Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Body Mass Index" in Association With Time to First Peritonitis Episode in the Whole Study Group.26 ± 426 ± 426 ± 4
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.012 (Unit of measure: Body mass index (hazard ratio per 5 kg/m2). P \< 0,05 is regarded as statistically significant.) · Hazard ratio (hr): 1.20 · 95% CI 1.04 to 1.38Univariable Cox regression.
Other pre-specifiedAnalysis of "Diabetic Nephropathy" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable "Diabetic nephropathy" as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Diabetic Nephropathy" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Diabetic Nephropathy" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.6387150
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.56 (Unit of measure: Diabetic nephropathy as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 0.91 · 95% CI 0.66 to 1.25Univariable Cox regression
Other pre-specifiedAnalysis of "Glomerulonephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable "Glomerulonephritis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Glomerulonephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Glomerulonephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.8787174
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.74 (Unit of measure: Glomerulonephritis as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.05 · 95% CI 0.78 to 1.42Univariable Cox regression
Other pre-specifiedAnalysis of "Tubulointerstitial Nephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable "Tubulointerstitial nephritis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Tubulointerstitial Nephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Tubulointerstitial Nephritis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.171734
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.42 (Unit of measure: Tubulointerstitial nephritis as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.25 · 95% CI 0.73 to 2.15Univariable Cox regression
Other pre-specifiedAnalysis of "Polycystic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable "Polycystic kidney disease" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Polycystic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Polycystic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.402969
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.038 (Unit of measure: Polycystic kidney disease as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 0.56 · 95% CI 0.33 to 0.97Cox regression
Other pre-specifiedAnalysis of "Ischemic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable "Ischemic kidney disease" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Ischemic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Ischemic Kidney Disease" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.112
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.52 (Unit of measure: Ischemic kidney disease as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.92 · 95% CI 0.27 to 13.68Univariable Cox regression
Other pre-specifiedAnalysis of "Nephrosclerosis/Hypertension" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable "Nephrosclerosis/hypertension" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Nephrosclerosis/Hypertension" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Nephrosclerosis/Hypertension" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.7866144
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.13 (Unit of measure: Nephrosclerosis/Hypertension as primary cause of kidney failure vs. all other causes. P \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.26 · 95% CI 0.93 to 1.71Univariable Cox regression
Other pre-specifiedAnalysis of "Other Diagnosis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable "Other diagnosis" as primary cause of kidney failure is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Other Diagnosis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Other Diagnosis" as Primary Cause of Kidney Failure in Association With Time to First Peritonitis Episode in the Whole Study Group.382664
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.71 (Unit of measure: "Other Diagnosis as primary cause of kidney failure" vs. all other causes. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 0.92 · 95% CI 0.58 to 1.45Univariable Cox regression
Other pre-specifiedAnalysis of "Unknown Primary Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.

Outcome data for the baseline variable "Unknown primary cause of kidney failure" as primary cause of kidney failure are presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Unknown Primary Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Unknown Primary Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.161834
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.89 (Unit of measure: Unknown cause as primary cause of kidney failure vs. all other causes. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.04 · 95% CI 0.57 to 1.91Univariable Cox regression
Other pre-specifiedAnalysis of "Comorbidity" (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Comorbidity" in association with time to first peritonitis episode is presented. The Stoke grading system of cardiovascular comorbidity was used to reflect the comorbid burden. Comorbidity was graded "0" when absent, "1" when 1 or 2, and "2" when 3 or more conditions were present. The association of baseline variables (at PD start) or time-updated variables with time to first was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Comorbidity" (According to Stoke Comorbidity Score) in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Stoke score 0 (No comorbidity)193202395
Stoke score 1-2 (1-2 comorbidities)128117245
Stoke Score > 2 (More than 2 comorbidities)191231
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.28 (Unit of measure: Comorbidity at PD start according to Stoke comorbidity score (1-2 vs. 0) i.e. 1-2 comorbidities vs. no comorbidity. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.16 · 95% CI 0.88 to 1.53Univariable Cox regression
  • The Whole Study Group · Regression, Cox · p = 0.44 (Unit of measure: Comorbidity at PD start according to Stoke comorbidity score (\>2 vs. 0) i.e. more than 2 comorbidities vs. no comorbidity. P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.29 · 95% CI 0.68 to 2.45Univariable Cox regression
Other pre-specifiedAnalysis of "Ischemic Heart Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Ischemic heart disease" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Ischemic Heart Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Ischemic Heart Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.6062122
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.07 (Unit of measure: Ischemic heart disease as comorbidity at baseline (yes vs. no). P \< 0.5 is regarded as statistically significant.) · Hazard ratio (hr): 1.35 · 95% CI 0.97 to 1.87Univariable Cox regression
Other pre-specifiedAnalysis of "Peripheral Vascular Disease or Stroke" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Peripheral vascular disease or stroke" (yes vs. no) in association with time to first peritonitis episode is presented. Peripheral vascular disease or stroke"" includes distal aortic, renovascular, and cerebrovascular disease as well as symptomatic disease in these vascular territories e.g. cerebrovascular accident, claudication, amputation or significant stenosis \>50% on vascular imaging or Doppler ultrasound. The association of baseline variables with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Peripheral Vascular Disease or Stroke" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Peripheral Vascular Disease or Stroke" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.392766
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.80 (Unit of measure: "Peripheral vascular disease or stroke" as comorbidity at PD start (yes vs. no). P-value \<0.05 regarded as statistically significant.) · Hazard ratio (hr): 1.06 · 95% CI 0.69 to 1.63Univariable Cox regression
Other pre-specifiedAnalysis of "Left Ventricular Dysfunction" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Left ventricular dysfunction" (yes vs. no) in association with time to first peritonitis episode is presented. Left ventricular dysfunction includes clinical evidence of pulmonary oedema not attributable to errors in fluid balance or moderate to severe left ventricular dysfunction on echocardiography, or clinical signs of symptomatic moderate to severe heart failure. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Left Ventricular Dysfunction" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Left Ventricular Dysfunction" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.373471
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.53 (Unit of measure: "Left ventricular dysfunction as comorbidity" (yes vs. no). P-value \<0.05 is significant.) · Hazard ratio (hr): 1.15 · 95% CI 0.75 to 1.77Univariable Cox regression
Other pre-specifiedAnalysis of "Diabetes Mellitus as Comorbidity" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Diabetes mellitus as comorbidity" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Diabetes Mellitus as Comorbidity" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Diabetes Mellitus as Comorbidity" in Association With Time to First Peritonitis Episode in the Whole Study Group.252449
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.099 (Unit of measure: "Diabetes Mellitus as Comorbidity" (yes vs. no). P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.44 · 95% CI 0.93 to 2.22Univariable Cox regression
Other pre-specifiedAnalysis of "System Collagen Vascular Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "System collagen vascular disease" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "System Collagen Vascular Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "System Collagen Vascular Disease" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.201030
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.22 (Unit of measure: "System Collagen Vascular Disease" as Comorbidity" (yes vs. no). P-value \<0.05 is regarded as statistically significant.) · Hazard ratio (hr): 0.62 · 95% CI 0.29 to 1.32Univariable Cox regression
Other pre-specifiedAnalysis of "Other Significant Pathology" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Other significant pathology" (yes vs. no) in association with time to first peritonitis episode is presented. Other significant pathology includes diseases like severe chronic obstructive airway disease, liver cirrhosis, psychotic illness, and severe osteoarthritis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Other Significant Pathology" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Other Significant Pathology" as Comorbidity in Association With Time to First Peritonitis Episode in the Whole Study Group.423072
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.79 (Unit of measure: "Other Significant Pathology" as Comorbidity (yes vs. no). P \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 0.94 · 95% CI 0.61 to 1.46Univariable Cox regression
Other pre-specifiedAnalysis of "Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Diabetes mellitus as comorbidity or main cause of kidney failure" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure" in Association With Time to First Peritonitis Episode in the Whole Study Group.88111199
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.69 (Unit of measure: "Diabetes Mellitus as Comorbidity or Main Cause of Kidney Failure" (yes vs. no". P-value \< 0.05 is regarded as significantly significant.) · Hazard ratio (hr): 1.06 · 95% CI 0.80 to 1.40Univariable Cox regression
Other pre-specifiedAnalysis of "Previous Kidney Replacement Therapy" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Previous kidney replacement therapy" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Previous Kidney Replacement Therapy" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Previous Kidney Replacement Therapy" in Association With Time to First Peritonitis Episode in the Whole Study Group.6861129
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.86 (Unit of measure: "Previous Kidney Replacement Therapy" (yes vs. no). P-value \< 0.05 is regarded as significant.) · Hazard ratio (hr): 1.03 · 95% CI 0.74 to 1.42Univariable Cox regression
Other pre-specifiedAnalysis of "Functional Status (Karnofsky Score)" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Functional status (Karnofsky score)" in association with time to first peritonitis episode in the whole study group is presented. Functional status was estimated using the Karnofsky Performance Scale with scores from 100 (Normal, no complains, no evidence of disease) to 0 (dead). 90 = Able to carry on normal activity, minor signs or symptoms of disease. 80 = Normal activity with effort, some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or do active work. 60 = Requires occasional assistance, but able to to care for most of her/his needs. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Median · Karnofsky score numbers
Analysis of "Functional Status (Karnofsky Score)" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Karnofsky score numbersThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Functional Status (Karnofsky Score)" in Association With Time to First Peritonitis Episode in the Whole Study Group.90 (80 to 95)90 (80 to 90)90 (80 to 90)
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.60 (Unit of measure: Functional status (Karnofsky score). Functional status was estimated by the Karnofsky Performance Scale. Scores from 100 (Normal, no complaints) to 0 = (dead). 90 = Able to carry on normal activity. 80 = Normal activity with effort.) · Hazard ratio (hr): 1.00 · 95% CI 0.98 to 1.01Univariable Cox regression
  • The Whole Study Group · Regression, Cox · p = 0.48 (Unit of measure: Functional status (Karnofsky score 80 - 90 vs. 100). Functional status was estimated by the Karnofsky Performance Scale (see Statistical analysis 1). P \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.13 · 95% CI 0.81 to 1.57Univariable Cox regression
  • The Whole Study Group · Regression, Cox · p = 0.63 (Unit of measure: Functional status (Karnofsky score \< 80 vs. 100). Functional status was estimated by the Karnofsky Performance Scale (see Statistical analysis 1). P \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 1.13 · 95% CI 0.69 to 1.85
Other pre-specifiedAnalysis of the Social Factor "Visual Impairment" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline variable "Visual impairment" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Social Factor "Visual Impairment" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Social Factor "Visual Impairment" in Association With Time to First Peritonitis Episode in the Whole Study Group.172845
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.71 (Unit of measure: Visual impairment (yes vs. no). P-value \< 0.05 is regarded as statistically significant.) · Hazard ratio (hr): 0.90 · 95% CI 0.54 to 1.53
Other pre-specifiedAnalysis of the Social Factor "Impaired Hand Function" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor "Impaired hand function" (yes vs. no) in association with time to first peritonitis episode is presented. The impairment of hand function was unspecified. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Social Factor "Impaired Hand Function" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Social Factor "Impaired Hand Function" in Association With Time to First Peritonitis Episode in the Whole Study Group.232144
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.29 (Unit of measure: "Impaired Hand Function" (yes vs. no). P-value \< 0.05 is considered statistically significant.) · Hazard ratio (hr): 1.29 · 95% CI 0.80 to 2.06Univariable Cox regression
Other pre-specifiedAnalysis of the Social Factor "Working Full or Part Time" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor "Working full or part time" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Social Factor "Working Full or Part Time" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Social Factor "Working Full or Part Time" in Association With Time to First Peritonitis Episode in the Whole Study Group.103102205
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.016 (Units of measure: "Working full or part time (yes vs no)". P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 0.68 · 95% CI 0.50 to 0.93Univariable Cox regression
Other pre-specifiedAnalysis of the Social Factor "Retired" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor "Retired" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Social Factor "Retired" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Social Factor "Retired" in Association With Time to First Peritonitis Episode in the Whole Study Group.184169353
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.041 (Unit of measure: "Retired" (yes vs. no). P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 1.32 · 95% CI 1.01 to 1.73Univariable Cox regression
Other pre-specifiedAnalysis of the Social Factor "Living Alone" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor "Living alone" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Social Factor "Living Alone" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Social Factor "Living Alone" in Association With Time to First Peritonitis Episode in the Whole Study Group.9177168
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.064 (Unit of measure: "Living alone" (yes vs. no). P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 1.31 · 95% CI 0.98 to 1.76Univariable Cox regression
Other pre-specifiedAnalysis of the Social Factor "Need for Translation/Interpreter" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor "Working full or part time" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Social Factor "Need for Translation/Interpreter" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Social Factor "Need for Translation/Interpreter" in Association With Time to First Peritonitis Episode in the Whole Study Group.91322
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.14 (Unit of measure: "Need for translation/interpreter" (yes vs. no). P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 0.48 · 95% CI 0.18 to 1.29Univariable Cox regression
Other pre-specifiedAnalysis of the Social Factor "Current Smoking" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline social factor "Current smoking" (yes vs. no) in association with time to first peritonitis episode is presented. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Social Factor "Current Smoking" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Social Factor "Current Smoking" in Association With Time to First Peritonitis Episode in the Whole Study Group.343973
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.60 (Unit of measure: "Current smoking" (yes vs. no). P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 1.11 · 95% CI 0.75 to 1.65Univariable Cox regression
Other pre-specifiedAnalysis of the Biochemical Characteristic "Serum Creatinine" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic Serum creatinine (micromol/L) in association with time to first peritonitis episode is presented. Serum creatinine was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Mean · Micromol/L
Analysis of the Biochemical Characteristic "Serum Creatinine" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Micromol/LThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Biochemical Characteristic "Serum Creatinine" in Association With Time to First Peritonitis Episode in the Whole Study Group.640 ± 234650 ± 208645 ± 222
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.18 (Unit of measure: Serum creatinine (HR per 100 micromol/L". P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 0.96 · 95% CI 0.90 to 1.02Univariable Cox regression
Other pre-specifiedAnalysis of the Biochemical Characteristic "Serum Urea" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic Serum urea (mmol/L) in association with time to first peritonitis episode is presented. Serum urea was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Mean · mmol/L
Analysis of the Biochemical Characteristic "Serum Urea" in Association With Time to First Peritonitis Episode in the Whole Study Group.
mmol/LThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Biochemical Characteristic "Serum Urea" in Association With Time to First Peritonitis Episode in the Whole Study Group.28 ± 928 ± 928 ± 9
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.34 (Unit of measure: Serum urea (Hazard ratio per 5 mmol/L). P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 0.96 · 95% CI 0.90 to 1.04Univariable Cox regression
Other pre-specifiedAnalysis of the Biochemical Characteristic "Serum Albumin" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic" Serum albumin" (g/L) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Mean · g/L
Analysis of the Biochemical Characteristic "Serum Albumin" in Association With Time to First Peritonitis Episode in the Whole Study Group.
g/LThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Biochemical Characteristic "Serum Albumin" in Association With Time to First Peritonitis Episode in the Whole Study Group.34 ± 634 ± 634 ± 6
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.019 (Unit of measure: Serum albumin (Hazard ratio per 5g/L). P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 0.88 · 95% CI 0.79 to 0.98Univariable Cox regression
Other pre-specifiedAnalysis of the Biochemical Characteristic "Serum Albumin (< 35 g/L vs. 35 g/L or More)" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic "Serum albumin" (\< 35 g/L vs. 35 g/L or more) in association with time to first peritonitis episode is presented. Serum albumin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Biochemical Characteristic "Serum Albumin (< 35 g/L vs. 35 g/L or More)" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Serum albumin <35 g/L169169338
Serum albumin 35 g/L or more171162333
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.013 (Unit of measure: Serum albumin (\<35 g/L vs. 35 g/L or more). P-value \<0.05 is regarded as significant.) · Hazard ratio (hr): 1.41 · 95% CI 1.08 to 1.82Univariable Cox regression
  • The Whole Study Group · Regression, Cox · p = 0.015 (Unit of measure: Serum albumin (\<35 g/l vs. 35 g/l or more). P-value \<0.05 is regarded as significant.) · Hazard ratio (hr): 1.39 · 95% CI 1.06 to 1.82Multivariable Cox regression
Other pre-specifiedAnalysis of the Biochemical Characteristic "Haemoglobin" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of the baseline biological characteristic "Serum haemoglobin" (mmol/L) in association with time to first peritonitis episode is presented. Serum haemoglobin was measured just before the start of peritoneal dialysis. The association of baseline variables (at PD start) with time to first peritonitis was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Mean · mmol/L
Analysis of the Biochemical Characteristic "Haemoglobin" in Association With Time to First Peritonitis Episode in the Whole Study Group.
mmol/LThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Biochemical Characteristic "Haemoglobin" in Association With Time to First Peritonitis Episode in the Whole Study Group.110 ± 14111 ± 12111 ± 13
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.61 (Unit of measure: Haemoglobin (HR per 10 g/L). P-value \< 0.05 was considered significant.) · Hazard ratio (hr): 0.76 · 95% CI 0.27 to 2.17Univariable Cox regression
Other pre-specifiedAnalysis of the Use of a "Corticosteroid Drug" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The analysis of the use of a "Corticosteroid drug" (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Time-dependent univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on corticosteroid treatment at baseline is presented below.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Use of a "Corticosteroid Drug" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Use of a "Corticosteroid Drug" in Association With Time to First Peritonitis Episode in the Whole Study Group.444387
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.33 (Unit of measure. The time-dependent variable "Corticosteroid treatment" (yes vs. no). Time-updated data were used. P-value \< 0.05 was considered significant.) · Hazard ratio (hr): 0.82 · 95% CI 0.54 to 1.23Time-dependent univariable Cox regression
Other pre-specifiedAnalysis of "Cytotoxic Treatment" in Association With Time to First Peritonitis Episode in the Whole Study Group.

Analysis of "Cytotoxic treatment" (yes vs.no) in association with time to first peritonitis episode is presented. This variable may vary with time and is thus time-dependent. The variable was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode was used in the time-dependent univariable and multivariable Cox regression analyses of the association of the variable with time to first peritonitis episode. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants on cytotoxic treatment at baseline is presented below.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Cytotoxic Treatment" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Cytotoxic Treatment" in Association With Time to First Peritonitis Episode in the Whole Study Group.272552
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.60 (Unit of measure: Cytotoxic treatment (yes vs. no). Time-updated data was used. P-value \< 0.05 was considered significant.) · Hazard ratio (hr): 1.14 · 95% CI 0.70 to 1.84Time-updated univariable Cox regression
Other pre-specifiedAnalysis of "Type of Start of Peritoneal Dialysis" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of "Type of start of peritoneal dialysis" in association with time to first peritonitis episode is presented. The type of start of peritoneal dialysis could be either planned or acute. The association of "Type of start of peritoneal dialysis" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Type of Start of Peritoneal Dialysis" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Planned PD start300278578
Acute PD start405393
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.72 (Unit of measure: Type of PD start (planned vs. acute). P-value \< 0.05 was considered significant.) · Hazard ratio (hr): 1.07 · 95% CI 0.73 to 1.57Univariable Cox regression
Other pre-specifiedAnalysis of "The Use of Antibiotics Prior to PD Catheter Insertion" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The statistical analysis of "The use of antibiotics prior to PD catheter insertion" (yes vs. no) in association with time to first peritonitis episode is presented. Antibiotics prior to PD catheter insertion may be given to prevent infection. The association of "The use of antibiotics prior to PD catheter insertion" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The count of participants who used antibiotics prior to PD catheter insertion is presented below.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "The Use of Antibiotics Prior to PD Catheter Insertion" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "The Use of Antibiotics Prior to PD Catheter Insertion" in Association With Time to First Peritonitis Episode in the Whole Study Group.305305610
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.77 (Unit of measure: Antibiotics prior to PD catheter insertion (yes vs. no). P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 1.08 · 95% CI 0.66 to 1.76Univariable Cox regression
Other pre-specifiedAnalysis of "the Type of PD Catheter Used" in Association With Time to First Peritonitis Episode in the Whole Study Group.

PD catheters could be either be straight or coiled. The statistical analysis of "the type of PD catheter used" (straight vs. coiled) in association with time to first peritonitis episode is presented. The association of "the type of PD catheter used" in association with time to first peritonitis episode was studied in the whole study group. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "the Type of PD Catheter Used" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Straight PD catheter7876154
Coiled PD catheter262255517
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.68 (Unit of measure: Type of PD-catheter (straight vs. coiled). P-value \< 0.05 is considered significant.) · Hazard ratio (hr): 0.94 · 95% CI 0.68 to 1.28Univariable Cox regression
Other pre-specifiedAnalysis of "PD Modality (CAPD/APD)" in Association With Time to First Peritonitis Episode in the Whole Study Group.

"PD modality (CAPD/APD)" in Association With Time to First Peritonitis Episode in the whole study group was studied. A participant either used CAPD (Continuous Ambulatory Peritoneal Dialysis) or APD (Automated Peritoneal Dialysis) but may change the PD modality during the study. This variable may vary with time and is thus time-dependent. The time-dependent data was recorded at all study visits. The value recorded at the study visit which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data was included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The c

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "PD Modality (CAPD/APD)" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
CAPD at PD start278262540
APD at PD start6269131
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.10 (Unit of measure: PD modality (CAPD, continuous ambulatory peritoneal dialysis vs. APD, automated peritoneal dialysis). Time-updated data were used. P-value \< 0.05 is regarded as significant.) · Hazard ratio (hr): 1.26 · 95% CI 0.96 to 1.66Univariable time-dependent Cox regression
Other pre-specifiedAnalysis of "Number of PD Bags Used/24h" in Association With of Time to First Peritonitis Episode in the Whole Study Group.

The association of the "Number of PD bags used/24h" and Time to First Peritonitis Episode was studied. The number of PD bags used/24h many vary with time, as this variable is thus time-dependent. Data from PD start is presented below. As described in "Outcome measure 39", data was collected at each study visit. We recorded the number of bags connected to the PD catheter/24h in CAPD patients and in APD patients we recorded the number of bags connected to the tubing set/24h adding the daily number of bags connected to the PD catheter if additional manual daytime exchanges were used. The time-dependent data was included in a time-dependent univariable Cox regression to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Median · Number of PD bags/24h at PD start
Analysis of "Number of PD Bags Used/24h" in Association With of Time to First Peritonitis Episode in the Whole Study Group.
Number of PD bags/24h at PD startThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Number of PD Bags Used/24h" in Association With of Time to First Peritonitis Episode in the Whole Study Group.4 (1 to 5)4 (1 to 6)4. (1 to 6)
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = < 0.0001 (Unit of measure: Number of PD bags used/24h. Time-updated data was used. P-value \<0.05 was regarded as significant.) · Hazard ratio (hr): 1.35 · 95% CI 1.17 to 1.57Univariable time-dependent Cox regression. (The result of multivariable Cox regression is presented in Statistical analysis 2)
  • The Whole Study Group · Regression, Cox · p = <0.0005 (Unit of measure: Number of PD bags used /24h. Time-updated data was used. P-value \< 0.05 was regarded as significant.) · Hazard ratio (hr): 1.32 · 95% CI 1.13 to 1.54Multivariable time-dependent Cox regression
Other pre-specifiedAnalysis of "The Volume of Dialysis Fluid Used/24h" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The association of "The Volume of Dialysis Fluid used/24h" with the time to first peritonitis episode is analysed in the whole study group. The volume of dialysis fluid used per 24h can vary with time and is thus time-dependent. The dialysis fluid volume/24h used at PD start is reported below. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The time-dependent data were included in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Median · Liter of PD fluid used/24h at PD start
Analysis of "The Volume of Dialysis Fluid Used/24h" in Association With Time to First Peritonitis Episode in the Whole Study Group.
Liter of PD fluid used/24h at PD startThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "The Volume of Dialysis Fluid Used/24h" in Association With Time to First Peritonitis Episode in the Whole Study Group.8.0 (1.5 to 18.5)8.0 (1.5 to 22.0)8.0 (1.5 to 22.0)
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.13 (Unit of measure: Volume of dialysis fluid/24h (L). Time-updated data was used. P-value \< 0.05 was considered significant.) · Hazard ratio (hr): 1.03 · 95% CI 0.99 to 1.08Univariable time-dependent Cox regression
Other pre-specifiedAnalysis of "Need of Help With Exit-site Care" in Association With Time to First Peritonitis Episode in the Whole Study Group.

The exit site is the point where the PD catheter emerges from the skin of the abdomen. The number of "participants who needed of help with exit-site care at PD start is reported below. The need of this help may vary with time. This variable is thus time-dependent. The time-dependent data were recorded at all study visits. The value recorded at the study visit, which was closest to and prior to the first peritonitis episode for each participant was used in the analyses. The data were included as time-varying covariates in a time-dependent Cox regression. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of "Need of Help With Exit-site Care" in Association With Time to First Peritonitis Episode in the Whole Study Group.
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of "Need of Help With Exit-site Care" in Association With Time to First Peritonitis Episode in the Whole Study Group.8479163
Statistical analysis
  • The Whole Study Group · Regression, Cox · p = 0.79 (Unit of measure: Help needed with exit-site care (yes vs. no). Time-updated data was used. P-value \< 0.05 was considered significant.) · Hazard ratio (hr): 1.04 · 95% CI 0.77 to 1.41Univariable time-dependent Cox regression
Other pre-specifiedAnalysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode

Analysis of the association of the Study group (retraining group vs. control group) with time to first peritonitis episode is presented. Univariable Cox regression was used to identify variables significantly associated with time to first peritonitis episode. Multivariable Cox regression was performed using a backward elimination procedure stopping when all remaining factors were significant at p \< 0.05. No collinearity among the factors affecting the backward elimination procedure was found. The risk (hazard ratio) associated with each studied variable is reported.

Time frame:
Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis. The time (days) to the first peritonitis episode was calculated for each participant.
Reported as:
Count of participants · Participants
Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode
ParticipantsThe Retraining GroupThe Control GroupThe Whole Study Group
Analysis of the Association of the Study Group (Retraining Group vs. the Control Group) With Time to First Peritonitis Episode340331671
Statistical analysis
  • The Retraining Group vs The Control Group · Regression, Cox · p = 0.52 (Unit of measure: Study group (retraining group vs. control group). P-value \<0.05 is regarded as significant.) · Hazard ratio (hr): 0.92 · 95% CI 0.71 to 1.19

Adverse events

Collected over The study participants were included from 18 Jan 2010 to 31 Dec 2014. They were followed up to 3 years. The study ended on 31 Dec 2015. No adverse events were reported in this study, which compared the number of peritonitis episodes which occurred in subjects with peritoneal dialysis who were given extra training in performing peritoneal dialysis and those who who were treated according the ordinary routines.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
The Follow-up Group27/340 (7.9%)0/340 (0%)0/340 (0%)
Control Group29/331 (8.8%)0/331 (0%)0/331 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)The Retraining GroupControl GroupTotal
Median64 (19 to 87)62 (19 to 88)62 (19 to 88)
Sex: Female, Male
Sex: Female, Male(Participants)The Retraining GroupControl GroupTotal
Female111114225
Male229217446
Region of Enrollment
Region of Enrollment(participants)The Retraining GroupControl GroupTotal
Sweden191192383
Latvia252550
Netherlands252651
Denmark322759
Estonia11920
Norway302656
Finland222244
United Kingdom448
Age 65 years or more
Age 65 years or more(Participants)The Retraining GroupControl GroupTotal
Count of participants164144308
Body weight
Body weight(Kg)The Retraining GroupControl GroupTotal
Mean77 ± 1579 ± 1678 ± 15
Body mass index
Body mass index(Kg/m2)The Retraining GroupControl GroupTotal
Mean26 ± 426 ± 426 ± 4
Primary cause of end-stage kidney disease
Primary cause of end-stage kidney disease(Participants)The Retraining GroupControl GroupTotal
Diabetic nephropathy6387150
Glomerulonephritis8787174
Tubulointerstitial nephritis171734
Polycystic kidney disease402969
Ischemic kidney kisease112
Nephrosclerosis/Hypertension7866144
Other diagnosis382664
Unknown cause161834
Comorbidity
Comorbidity(participants)The Retraining GroupControl GroupTotal
Ischemic heart disease6062122
Peripheral vascular disease and stroke392766
Left ventricular dysfunction373471
Diabetes (comorbidity or main cause of kidney failure)88111199
Collagen vascular disease201030
Other significant pathology423072

16 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Department of Nephrology, Sahlgrenska University Hospital
    Gothenburg, SE-413 45, Sweden
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Dec 2012 and a completion of Dec 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2025, 13 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 10, 2011
First posted
Feb 11, 2011
Start
Jan 2010
Primary completionActual
Dec 2012
CompletionActual
Dec 31, 2015
Results first posted
Dec 16, 2025
Last update
Dec 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01293799
Responsible party
Susanne Ljungman (professor, Sahlgrenska University Hospital) — Principal investigator
First posted
Feb 11, 2011
Start date
Jan 2010
Primary completion
Dec 2012
Completion
Dec 31, 2015
Results posted
Dec 16, 2025
Last update
Dec 16, 2025

Study contacts

Susanne Ljungman, Prof. emer.
study director · Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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