Prevention of Peritonitis in Peritoneal Dialysis

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

Interventions

BEHAVIORAL

Retraining

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

Sponsors & Collaborators

• Odense University Hospital

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Sykehuset Innlandet HF

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Pauls Stradins Clinical University Hospital

  collaborator OTHER

• Tartu University Hospital

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• Sahlgrenska University Hospital

  lead OTHER

Principal Investigators

• Susanne Ljungman, Prof. emer. · Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-01-31

Primary Completion

2012-12-31

Completion

2015-12-31

Countries

• Sweden

Study Locations