Prevention of Peritonitis in Peritoneal Dialysis (PEPS)

Sahlgrenska University Hospital

Status: Completed

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

Treatments: Behavioral: Retraining

Study type: Interventional

Funder types: Other

Identifiers

NCT01293799

Dnr 590-09

Details and patient eligibility

About

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.

Full description

BACKGROUND See above.

AIMS The primary aim of this trial is to study if regular follow-up of PD patients with testing of their theoretical and practical knowledge (hereafter called "new type of follow-up") can reduce the time to first peritonitis episode. Secondary aims were to study if the new type of follow-up could reduce the incidence of peritonitis, the technique failure rate related to peritonitis, and the time of hospitalization related to peritonitis compared to a routine regimen. For specific aims, see "Outcome measures" below. A further aim was to study risk factors for peritonitis.

PATIENTS AND METHODS The study is a randomized, multi-centre investigation intending to enclose 750 new PD patients in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom. Inclusion was finished on December 31, 2014. The study will go on until the last included patient has taken part of the study for one year. The study will thus be terminated on December 31, 2015.

The study includes a retraining group and a control group. The intervention in the retraining group consists of regular testing of theoretical and practical knowledge regarding PD with focus on infection prophylaxis including retraining if needed until the test goals are reached. The control group will be treated according to the routines of the center. Peritonitis is defined according to International Society for Peritoneal Dialysis (SPD) guidelines (Peritoneal Dialysis International 2005;25:107-131)

The baseline PD training will be the same at all participating centres and follow international recommendations. In addition, fluorescent alcohol and a UV lamp will be used to control the result of hand disinfection in all patients once during the initial PD training. Thereafter this method will only be used in the retraining group..

In the retraining group, the knowledge from the basal training will be tested at 1, 3, 6, and 12 months after PD start, every sixth month thereafter, and after every episode of peritonitis. Such testing will also be performed at restart of PD and includes two types of tests:

1. The patient will fill in a questionnaire with theoretical and practical questions with focus on infection and infection prophylaxis during PD treatment. Goal: At least 80% of the questions should be correct. If the goal is not reached, further training will be given until the goal is reached.
2. The patient will perform a practical test including hand disinfection, PD exchange technique, and exit-site care. Hand disinfection skills will be controlled with the help of fluorescent alcohol and a UV lamp. Goal: All steps of the practical test should be correctly performed. If not, further training will be given until the goal is reached.

Enrollment: 713 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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713 participants in 2 patient groups

The retraining group

Experimental group

Description:

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.

Treatment:

Behavioral: Retraining

Control group

No Intervention group

Description:

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