N/A
N=671
Prevention of Peritonitis in Peritoneal Dialysis
Kidney Failure, Chronic · Peritoneal Dialysis-associated Peritonitis · Dialysis Capd Infection
Bottom Line
View on ClinicalTrials.gov: NCT01293799 ↗Enrolled (actual)
671
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group — 381; 368 Days to first peritonitis episode — p=0.51
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Retraining (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sahlgrenska University Hospital
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group |
381; 368 | 0.51 |
| SECONDARY Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group |
0.29; 0.31 | 0.51 |
| SECONDARY Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group |
0.36; 0.33 | 0.54 |
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.
Eligibility Criteria
Inclusion Criteria
- Patient is able to perform PD without assistance
- Age 18 years old or more
Exclusion Criteria
- Previous PD-treatment less than 2 years ago
- Peritonitis before inclusion
- Active malignancy
- Participation in other studies during the study period which may affect outcome of the present study
Data sourced from ClinicalTrials.gov (NCT01293799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.