An interventional study of Peritoneal Dialysis in Heart Failure and Chronic Kidney Disease, sponsored by University of Nottingham. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-23.
Sponsored by University of Nottingham · Not applicable, Interventional, and Treatment
This trial is to establish whether ultrafiltration by peritoneal dialysis is a clinically effective treatment for patients with severe heart failure and moderate chronic kidney disease, thus improving quality of life and symptoms.
The trial is a multi-centre, prospective, randomised, unblended, controlled trial of intermittent PD with a single daily exchange of icodextrin plus best standard care versus best standard care for the treatment of severe HF and moderate CKD. A second exchange with glucose based solution may be given, should it be required in the investigator's/clinician's opinion. Investigators will randomise 130 participants for 32 weeks with randomisation stratified by participating centre. Participants will be recruited from specialist-led outpatient HF services in 6 NHS trusts and be managed by both cardiologists and nephrologists.
PD catheter insertion will occur according to the participating centre's institutional protocol. Treatment begins 1 week after catheter insertion and consists of a single nightly exchange.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 11 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University of Nottingham is the lead sponsor of 455 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
These participants will continue to receive standard HF care and Peritoneal Dialysis with a single daily exchange of icodextrin.
Procedure: Peritoneal Dialysis
These participants will continue to receive standard HF care.
One week after insertion of a PD catheter the intervention group will received a single nightly exchange, using dialysis fluid containing icodextrin; a variable proportion of participants may require a second exchange as directed by the consultant nephrologist as part of routine care. The second exchange would use dialysis fluid containing glucose, not icodextrin. Support and training will be given to each participant by the PD specialist team.
The primary end-point is a change of 25 metres walked
6 Minute Walk Test
Time frame: Baseline to week 28
Change in KCCQ score
Kansas City Cardiomyopathy Questionnaire
Time frame: Baseline to week 28
Change in SF36 score
Short Form 36 questionnaire
Time frame: Baseline to week 28
Change in Derby Evaluation of Illness online visual analogue scale
Derby Evaluation of Illness online visual analogue scale
Time frame: Baseline to week 28
Heart Failure related hospitalisations
Recording the number of hospitalisations relating to Heart Failure
Time frame: Baseline to week 28
All cause hospitalisations
Recording the number of hospitalisations for all causes
Time frame: Baseline to week 28
Heart failure related mortality
Recording the number of heart failure deaths
Time frame: Baseline to week 28
All cause mortality
Recording the number of all cause deaths
Time frame: Baseline to week 28
Episodes of PD associated peritoneal infection
Recording the numbers of PD associated peritoneal infections
Time frame: Baseline to week 28
Adverse events spontaneously reported during the study
Recording and reporting adverse events
Time frame: Baseline to week 28
Is the Derby Evaluation of Illness online visual analogue scale more sensitive than pen and ink questionnaires
Comparison between the scores from pen and ink questionnaires and the online visual analogue scale
Time frame: Baseline to week 28
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University of Nottingham