An interventional study of Peritonitis treatment placed in APD and Peritonitis treatment with one exchange in CAPD in Secondary Peritonitis, sponsored by Universidad de Colima. Completed at 3 sites in Mexico. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Universidad de Colima · Not applicable, Interventional, and Treatment
The main infectious complication of peritoneal dialysis (PD) is bacterial peritonitis, which increases morbidity, mortality and conversion to hemodialysis.
In Mexico, 485 patients per million people undergo PD. The Mexican Institute of Social Security (IMSS) reported 55,101 patients with kidney failure, 59% on PD. Automated PD (APD) has contributed by reducing peritonitis. The treatment of peritonitis in APD is carried out by changing to continuous ambulatory peritoneal dialysis (CAPD) or by adding a CAPD/day replacement, increasing costs and delaying treatment. OBJECTIVE: To compare the efficacy of peritonitis antibiotic treatment applied in a DPA bag versus applied in a CAPD/day replacement plus APD in IMSS beneficiaries. MATERIAL AND METHODS: A non-inferiority, multicenter clinical trial was carried out with patients> 18 years of age in APD with peritonitis. Group 1 (g1) receives antibiotics in DPA bags, group 2 (g2) receives antibiotics in a CAPD / day exchange plus APD. The antibiotics applied were ceftazidime 1500 mg / day 14 days and vancomycin 20 mg / kg every 3 days, 5 doses adjusted according to culture, followed by cytology every 48 hours until clinical resolution. Considering resolved peritonitis when symptoms disappeared and white blood cells \<100 cells / mm3 were obtained in cytology. The Research and Ethics Committee approved the study. Relative risk (RR), relative risk reduction (RRR) were calculated. The Chi squared test, Student's t test, non-inferiority analysis was calculated considering p \<0.05 significant, SPSS 24 and Epi Info were used.
GENERAL DESCRIPTION OF THE STUDY.
PROCEDURES:
Patients with peritonitis (clinical, cytological sample with leukocytes >100/μL, and >50% Polymorphonuclear, taken from a dialysis exchange with 2 to 4 h of stay in the cavity, gram positive or positive culture of dialysis fluid) in Automated peritoneal dialysis of the general hospitals of the Mexican Institute zone Social Security No. 1, 10 and subzone 4 in the state of Colima. Two groups each of 32 patients were forming. Both created treatment groups received antibiotic management based on a double antibiotic scheme with Vancomycin and Ceftazidime via intraperitoneal (IP), the difference was for the treatment group (group 1) the application of the antibiotic through the 6L bags in APD through the cycler machine versus for the control group (group 2) the addition of a manual exchange (CAPD) of 6 hours of stay in extra cavity during the day for the application of the antibiotic plus the
Usual APD at night, the management of peritonitis in each group was established according to the following way:
Patients and relatives were informed in detail about the research project companions mentioning the objectives, risks and benefits of this, their Authorization for inclusion in the study by signing an endorsed informed consent by the national ethics and research committee of the IMSS. Through direct interview and review of the medical record, general and demographic data, data on associated pathologies, comorbidities, time in management with peritoneal dialysis, time of APD management, number of peritoneal catheters placed, APD prescription, diuresis residual, dose of erythropoietin, onset of the clinical picture of peritonitis, as well as the characteristics of the initial frame, time elapsed from the beginning of the frame to the performance of cytology. Possible triggering causes of the symptoms of peritonitis, the peritoneal dialysis technique was verified, other probable sites of infection and close contact was maintained with the medical team in charge of managing the cases hospitalized. After the diagnosis or suspicion of the case of peritonitis, a culture of fluid was taken from dialysis (LD) without antibiotics, and was reviewed at 48 and 72 h and 5 days after starting the treatment, collecting the report with corresponding antibiogram. Cultivation was the basis for making the decision to change the antibiotic according to the sensitivity and reported resistance. All patients underwent fluid cytology controls.
of PD every 48 hours in hospitalization or by scheduled appointment to PD programs from each hospital. The cytological ones were obtained from a manual exchange (CAPD) with 2 to 4 hours of stay in the cavity without antibiotics to determine the evolution of the symptoms of peritonitis. Through the cytological results and the clinical characteristics, the resolution of the peritonitis. At the beginning and at the end of the peritonitis, biochemical studies were performed: complete blood count (CBC), blood chemistry (QS), serum electrolytes (Na, K, Cl), general urinalysis (EGO) in case of residual urine, culture of site discharge catheter insertion in case of presenting and culture of peritoneal dialysis fluid.
Recorded the clinical features of peritonitis (cloudy PD fluid, abdominal pain, nause).
Exclusion Criteria:
This group will receive peritonitis treatment with one exchange on Continuous Ambulatory Peritoneal Dialysis per day. The initial antibiotic scheme will be with ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days) according to current management guidelines; adjusting the management according to the result of the culture, completing the antibiotic scheme for 14 to 21 days.
Device: Peritonitis treatment with one exchange in CAPD
This group will receive peritonitis treatment placed in Automated Peritoneal Dialysis. The initial antibiotic scheme will be with ceftazidime (1500mg/day) and vancomycin (20mg/kg every 3 days); adjusting the management according to the result of the culture, completing the antibiotic scheme for 14 to 21 days.
Device: Peritonitis treatment placed in APD
Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.
Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.
Peritonitis Resolved
We consider the problem resolved when symptoms (nausea, vomiting, abdominal pain, fever, turbid fluid) have disappeared and negative cytology has been obtained (leukocytes \<100 cells/mm3)
Time frame: 14 to 21 days
Death of Patient
Total number and percentage of patients
Time frame: 21 days
71 patients were diagnosed with peritonitis. 7 patients were excluded because, 5 patients did not meet criteria and 2 voluntary abandonment
| Milestone | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD |
|---|---|---|
| Started | 32 | 32 |
| Completed | 32 | 32 |
| Not completed | 0 | 0 |
We consider the problem resolved when symptoms (nausea, vomiting, abdominal pain, fever, turbid fluid) have disappeared and negative cytology has been obtained (leukocytes \<100 cells/mm3)
| participants | Peritonitis Treatment With ANTIBIOTIC in a Exchange in CAPD + Usual APD | Peritonitis Treatment Placed in APD |
|---|---|---|
| Peritonitis Resolved | 26 | 29 |
Total number and percentage of patients
| Participants | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD |
|---|---|---|
| Death of Patient | 2 | 2 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Peritonitis Treatment With One Exchange in CAPD | 2/32 (6.3%) | 0/32 (0%) | 0/32 (0%) |
| Peritonitis Treatment Placed in APD | 2/32 (6.3%) | 0/32 (0%) | 0/32 (0%) |
| Age, Categorical(Participants) | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 27 | 29 | 56 |
| >=65 years | 5 | 3 | 8 |
| Age, Continuous(years) | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD | Total |
|---|---|---|---|
| Mean | 51.5 ± 16.9 | 47.4 ± 4.6 | 49.42 ± 72.64 |
| Sex: Female, Male(Participants) | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD | Total |
|---|---|---|---|
| Female | 7 | 10 | 17 |
| Male | 25 | 22 | 47 |
| Race/Ethnicity, Customized(Participants) | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD | Total |
|---|---|---|---|
| spanish race | 32 | 32 | 64 |
| Region of Enrollment(participants) | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD | Total |
|---|---|---|---|
| Mexico | 32 | 32 | 64 |
| APD modality(Participants) | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD | Total |
|---|---|---|---|
| CCPD, continuous cycling peritoneal dialysi | 30 | 29 | 59 |
| INPD, intermittent nocturnal peritoneal dialysis | 2 | 3 | 5 |
| Body Mass Index(kg/m^2) | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD | Total |
|---|---|---|---|
| Mean | 27.9 ± 6.0 | 26.6 ± 4.9 | 27.23 ± 5.49 |
| APD per day, duration (hours)(Hours) | Peritonitis Treatment With One Exchange in CAPD | Peritonitis Treatment Placed in APD | Total |
|---|---|---|---|
| Mean | 9.6 ± 0.5 | 9.5 ± 0.6 | 9.55 ± 0.56 |
10 further baseline measures are reported on the registry.
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Universidad de Colima