Kidney Failure, Chronic Clinical Trial
— PEPSOfficial 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
Verified date | May 2019 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 713 |
Est. completion date | December 31, 2015 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Nephrology, Sahlgrenska University Hospital | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Central Hospital HF, Lillehammer, Norway (dr Dag Paulsen), Karolinska Institutet, Odense University Hospital, Denmark (dr Jorgen Jensen), Pauls Stradins Clinical University Hospital, Rigshospitalet, Denmark, Sheffield Teaching Hospitals NHS Foundation Trust, UK (dr Martin Wilkie), Tampere University Hospital, Tartu University Hospital, Tartu, Estonia (dr Mai Rosenberg) |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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