Trial record 5 of 357 for:    dialysis [CONDITION] OR dialysis [TREATMENT] | Open Studies

Prevention of Peritonitis in Peritoneal Dialysis (PEPS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Sahlgrenska University Hospital, Sweden
Sponsor:
Collaborators:
Odense University Hospital, Denmark (dr Jorgen Jensen)
Rigshospitalet, Denmark
Central Hospital HF, Lillehammer, Norway (dr Dag Paulsen)
Tampere University Hospital, Finland (dr Heikki Saha)
Pauls Stradins Clinical University Hospital, Riga, Latvia (dr Aivars Petersons)
Tartu University Hospital, Tartu, Estonia (dr Mai Rosenberg)
Karolinska Institutet
Academisch Medisch Centrum - Universiteit van Amsterdam (dr Dirk Struijk)
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: April 25, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Kidney Failure, Chronic
Peritoneal Dialysis-associated Peritonitis
Dialysis Capd Infection
Behavioral: Follow-up of PD patients´ theoretical and practical skills

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 hospitalization days due to peritonitis in the two groups will be compared.


Estimated Enrollment: 750
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The follow-up group
The follow-up group is the intervention group, which will be compared with the control group.
Behavioral: Follow-up of PD patients´ theoretical and practical skills
Testing of patients knowledge and retraining if needed
No Intervention: Control group
Patients randomised to the control group will be treated according to the routines of the clinic

Detailed Description:

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 of 750 new PD patients in Sweden, Denmark, Norway, Finland, Estonia, Latvia, the Netherlands, and the United Kingdom. Inclusion time will be around 4 years. The study will go on until the last included patient has taken part of the study for one year. The study will be stopped at a certain date.

The study includes a follow-up group and a control group. The follow-up group will undergo regular testing of theoretical and practical knowledge regarding PD with focus on infection prophylaxis including retraining if needed. 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293799

Contacts
Contact: Susanne Ljungman, Prof. +46-(0)31-3421000 ext 28411 susanne.ljungman@vgregion.se
Contact: Lena Heijdenberg, PD nurse +46-(0)31-3421000 ext 28810 lena.heijdenberg@vgregion.se

Locations
Sweden
Department of Nephrology, Sahlgrenska University Hospital Recruiting
Gothenburg, Sweden, SE-413 45
Contact: Susanne Ljungman, Prof.    +46-(0)31-342100 ext 28941    susanne.ljungman@vgregion.se   
Contact: Lena Heijdenberg, PD nurse    +46-(0)31-342100 ext 28810    lena.heijdenberg@vgregion.se   
Principal Investigator: Susanne Ljungman, Prof.         
Sub-Investigator: Ulf Persson, M.D.         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Odense University Hospital, Denmark (dr Jorgen Jensen)
Rigshospitalet, Denmark
Central Hospital HF, Lillehammer, Norway (dr Dag Paulsen)
Tampere University Hospital, Finland (dr Heikki Saha)
Pauls Stradins Clinical University Hospital, Riga, Latvia (dr Aivars Petersons)
Tartu University Hospital, Tartu, Estonia (dr Mai Rosenberg)
Karolinska Institutet
Academisch Medisch Centrum - Universiteit van Amsterdam (dr Dirk Struijk)
Sheffield Teaching Hospitals NHS Foundation Trust, UK (dr Martin Wilkie)
Investigators
Study Director: Susanne Ljungman, Prof. Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden
  More Information

No publications provided

Responsible Party: Susanne Ljungman, professor, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT01293799     History of Changes
Other Study ID Numbers: Dnr 590-09
Study First Received: February 10, 2011
Last Updated: April 25, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Sahlgrenska University Hospital, Sweden:
Randomized
Peritoneal dialysis
Peritonitis
Primary prevention
Quality control
Self care
Kidney failure, chronic

Additional relevant MeSH terms:
Kidney Failure, Chronic
Peritonitis
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014