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N/A N=671 Randomized Prevention

Prevention of Peritonitis in Peritoneal Dialysis

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

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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