Prevention of Peritonitis in Peritoneal Dialysis

Study Overview
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Brief Summary
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BACKGROUND: Peritonitis remains a significant problem in peritoneal dialysis. 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 Peritoneal Dialysis (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 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 UK. The study will go on for 6 years.

Detailed Description
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BACKGROUND See above. AIMS 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 incidence of peritonitis, reduce the technique failure rate related to peritonitis, and reduce the time of hospitalization related to peritonitis compared to a routine regimen. For specific aims, see Outcome measures below. 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. Inclsuion 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 follow-up group and a control group. The intervention in the follow-up 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 ISPD guidelines (Perit Dial Int 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 follow-up group. In the follow-up 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. The follow-up includes two types of tests: 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. 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.

Official Title
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Prevention of Peritonitis in Patients With Peritoneal Dialysis - Effects of Regular Follow-up of Patients´ Theoretical Knowledge and Practical Skills With Focus on Infection Prophylaxis

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

Intervention / Treatment
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* Behavioral: Follow-up of PD patients´ theoretical and practical skills


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The follow-up group<br>The intervention in the follow-up 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: Follow-up of PD patients´ theoretical and practical skills<br>* Testing of patients knowledge and retraining if needed<br>|
| No Intervention: Control group<br>Patients randomised to the control group will be treated according to the routines of the clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of peritonitis during the whole study and the peritonitis-free survival both during the first 12 months after PD start and during the whole study wil be compared in the two groups. | The time to first peritonitis episode will be analysed as the cumulative time without peritonitis using the Cox regression model for mulivariate analyses. Log rank test will be used to compare the groups. Actuarial survival curves showing the proportions of peritonitis free patients over time in the two groups will be determined using the Kaplan-Meier life table method. Analysis will be sensored at death and kidney transplantation. | From PD start to either 12 months after PD start or to the whole study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors for peritonitis | The impact of age, sex, type of kidney disease, co-morbidity, physical handicap, and type of peritoneal dialysis on the risk of development of peritonitis will be studied | During the complete follow-up, i.e. from the day the first patient is included to one year after the last patient is included. The study will stop at a certain date | 
| Days of hospitalization due to peritonitis | The number of hospitalization days due to peritonitis in the two groups will be compared. | During the complete follow-up, i.e. from the day the first patient is included to one year after the last patient is included. The study will stop at a certain date | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, Peritoneal dialysis, Peritonitis, Primary prevention, Quality control, Self care, Kidney failure, chronic