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Prevention of Peritonitis in Peritoneal Dialysis (PEPS)

This study has been completed.
Sponsor:
Collaborators:
Odense University Hospital, Denmark (dr Jorgen Jensen)
Rigshospitalet, Denmark
Central Hospital HF, Lillehammer, Norway (dr Dag Paulsen)
Tampere University Hospital
Pauls Stradins Clinical University Hospital
Tartu University Hospital, Tartu, Estonia (dr Mai Rosenberg)
Karolinska Institutet
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sheffield Teaching Hospitals NHS Foundation Trust, UK (dr Martin Wilkie)
Information provided by (Responsible Party):
Susanne Ljungman, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01293799
First received: February 10, 2011
Last updated: January 7, 2016
Last verified: January 2016

February 10, 2011
January 7, 2016
January 2010
December 2015   (final data collection date for primary outcome measure)
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. [ Time Frame: From PD start to either 12 months after PD start or to the whole study ] [ Designated as safety issue: No ]
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.
Peritonitis-free survival at 12 months after PD start [ Time Frame: From PD start to 12 months after PD start ] [ Designated as safety issue: No ]
The time to first peritonitis during the first year of PD treatment will be analysed as the cumulative time without peritonitis using standard survival methodology including Cox regression model for multivariate analyses. Log rank follow-up will be used to compare the groups.
Complete list of historical versions of study NCT01293799 on ClinicalTrials.gov Archive Site
  • Risk factors for peritonitis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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
  • Days of hospitalization due to peritonitis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    The number of hospitalization days due to peritonitis in the two groups will be compared.
  • Incidence of peritonitis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    The incidence of peritonitis in the two groups during the complete follow-up will be compared
  • Risk factors for peritonitis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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
  • Days of hospitalization due to peritonitis [ Time Frame: 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 ] [ Designated as safety issue: No ]
    The number of hopitalisation days due to peritonitis in the two groups will be compared.
Not Provided
Not Provided
 
Prevention of Peritonitis in Peritoneal Dialysis
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

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.

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:

  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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Kidney Failure, Chronic
  • Peritoneal Dialysis-associated Peritonitis
  • Dialysis Capd Infection
Behavioral: Follow-up of PD patients´ theoretical and practical skills
Testing of patients knowledge and retraining if needed
  • Experimental: The follow-up group
    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.
    Intervention: Behavioral: Follow-up of PD patients´ theoretical and practical skills
  • No Intervention: Control group
    Patients randomised to the control group will be treated according to the routines of the clinic.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
750
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01293799
Dnr 590-09
Yes
Not Provided
Not Provided
Susanne Ljungman, Sahlgrenska University Hospital, Sweden
Sahlgrenska University Hospital, Sweden
  • Odense University Hospital, Denmark (dr Jorgen Jensen)
  • Rigshospitalet, Denmark
  • Central Hospital HF, Lillehammer, Norway (dr Dag Paulsen)
  • Tampere University Hospital
  • Pauls Stradins Clinical University Hospital
  • Tartu University Hospital, Tartu, Estonia (dr Mai Rosenberg)
  • Karolinska Institutet
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • Sheffield Teaching Hospitals NHS Foundation Trust, UK (dr Martin Wilkie)
Study Director: Susanne Ljungman, Prof. Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden
Sahlgrenska University Hospital, Sweden
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP