Prevention of Peritonitis in Peritoneal Dialysis

NCT01293799 | Completed Results DMC

• 1 other identifier: Dnr 590-09
• Study Type: interventional
• Target: 713
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

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.

  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 (2)

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

  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

• Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group

  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 (44)

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

  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.

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

  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.

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

  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.

Study Arms (2)

The retraining group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Retraining BEHAVIORAL

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

The retraining group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous PD-treatment less than 2 years ago
• Active malignancy
• Participation in other studies during the study period which may affect outcome of the present study

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Odense University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Sykehuset Innlandet HF: collaborator
• Tampere University Hospital: collaborator
• Pauls Stradins Clinical University Hospital: collaborator
• Tartu University Hospital: collaborator
• Karolinska Institutet: collaborator
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Department of Nephrology, Sahlgrenska University Hospital

Gothenburg, SE-413 45, Sweden

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Peritonitis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

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.

Results Point of Contact

• Title: Susanne Ljungman prof. emer. Director of the study
• Organization: Dept. of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden

susanne.ljungman@vgregion.se

+46-(0)31-3421000

Study Officials

• Susanne Ljungman, Prof. emer.

  Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: A non-commercial, physician-initiated, randomized, controlled, open-label, parallel-group, multicenter clinical trial. The participants were randomly assigned to either retraining with testing of their peritoneal dialysis knowledge (the retraining group) or to usual care (the control group).

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 31, 2015
• Last Updated: December 16, 2025
• Results First Posted: December 16, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)