Kidney Failure, ChronicPEPSNCT01293799

Prevention of Peritonitis in Peritoneal Dialysis

A study testing Retraining in people with Kidney Failure, Chronic and Peritoneal Dialysis-associated Peritonitis, run by Sahlgrenska University Hospital at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Chronic, Peritoneal Dialysis-associated Peritonitis, Dialysis Capd Infection
What is being tested?: Retraining
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 713 participants
Where: 1 siteSweden
Study dates: Jan 2010to 31 Dec 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient is able to perform PD without assistance
Age 18 years old or more

Who cannot join

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 locations and contacts

1 site in 1 country.

Sweden1 site

Department of Nephrology, Sahlgrenska University Hospital
Gothenburg, SE-413 45

Other trials in Sweden

About this study

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

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.

Read the detailed 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:

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.

Conditions: Kidney Failure, Chronic, Peritoneal Dialysis-associated Peritonitis, Dialysis Capd Infection
Being tested: Retraining
Keywords: Randomized, Peritoneal dialysis, Peritonitis, Primary prevention, Quality control, Self care, Kidney failure, chronic
Medical subject headings: Kidney Failure, Chronic, Peritonitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RetrainingBehavioural
Testing of the patients´ knowledge and retraining will be given if needed

Study groups in NCT01293799
Study group	Role	What they receive
The retraining group	Experimental	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. Receives: Behavioral: Retraining
Control group	No intervention	Patients randomised to the control group will be treated according to the routines of the clinic.

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group
Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.
Measured: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.

Secondary outcomes (2)

Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group
The incidence of a first peritonitis episode is expressed as the mean rate of a first peritonitis per patient year (event rate) with 95% confidence interval.
Measured: The participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. The time in study was calculated for each participant
Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group
The incidence of peritonitis episodes is expressed as the mean rate of peritonitis per patient year (event rate) with 95% confidence interval.
Measured: The participants were followed from 1 month after PD start (time of randomization) up to 36 months after start of peritoneal dialysis, The time (days) of participation in the study was calculated for each participant.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201031 Dec 2015

First posted11 Feb 2011 (estimated)
Study startJan 2010
Primary completionDec 2012
Study completion31 Dec 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: A non-commercial, physician-initiated, randomized, controlled, open-label, parallel-group, multicenter clinical trial. The participants were randomly assigned to either retraining with testing of their peritoneal dialysis knowledge (the retraining group) or to usual care (the control group).
Masking: None (open label)
Enrolment: 713 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01293799
Sponsor's protocol ID: Dnr 590-09
Acronym: PEPS
Status last verified: Nov 2025
First submitted: 10 Feb 2011
Last updated: 16 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01293799
Acronym / sponsor ID: PEPS / Dnr 590-09
Conditions: Kidney Failure, Chronic, Peritoneal Dialysis-associated Peritonitis, Dialysis Capd Infection
Keywords: Randomized, Peritoneal dialysis, Peritonitis, Primary prevention, Quality control, Self care, Kidney failure, chronic
Study type: Interventional
Recruitment status: Completed
Enrolment: 713 participants (actual)
Lead sponsor: Sahlgrenska University HospitalUniversity, hospital or other
Collaborators: Odense University Hospital, Copenhagen University Hospital, Rigshospitalet, Sykehuset Innlandet HF, Tampere University Hospital, Pauls Stradins Clinical University Hospital, Tartu University Hospital, Karolinska Institutet, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Sheffield Teaching Hospitals NHS Foundation Trust
Study start: Jan 2010
Primary completion: Dec 2012 (actual)
Study completion: 31 Dec 2015 (actual)
First posted: 11 Feb 2011 (estimated)
Results: Posted 16 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

BACKGROUND See above.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: A non-commercial, physician-initiated, randomized, controlled, open-label, parallel-group, multicenter clinical trial. The participants were randomly assigned to either retraining with testing of their peritoneal dialysis knowledge (the retraining group) or to usual care (the control group).

Arm	Type	Receives
The retraining group	Experimental	Behavioral: RetrainingThe 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.
Control group	No intervention	–Patients randomised to the control group will be treated according to the routines of the clinic.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient is able to perform PD without assistance
Age 18 years old or more

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RetrainingTesting of the patients´ knowledge and retraining will be given if needed	Behavioural	The retraining group

Primary outcome

Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group
Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.
Time (days) after the date of randomization to the date of the first peritonitis episode was calculated for each participant. The cumulative time without peritonitis using the Cox regression model from which unadjusted hazard ratios were calculated. Actuarial survival curves showing proportions of peritonitis-free participants over time in the two groups were estimated by means of the Kaplan-Meier method. Log rank follow-up was used to compare the survival curves. Patients who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.

2 secondary outcomes

Incidence of a First Dialysis-associated Peritonitis Episode in the Control and the Retraining Group
Time frame: The participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. The time in study was calculated for each participant
Incidence of All Peritonitis Episodes in the Control Group and the Retraining Group
Time frame: The participants were followed from 1 month after PD start (time of randomization) up to 36 months after start of peritoneal dialysis, The time (days) of participation in the study was calculated for each participant.

Results and safety

Results posted to the registry on 16 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The Retraining Group	340	67
Control Group	331	86

Primary outcome: Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group

Time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.. Median (Inter-Quartile Range). Unit: Days to first peritonitis episode

Measure	The Retraining Group n = 340	Control Group n = 331
Value	381 (154 to 555)	368 (161 to 617)

The Retraining Group vs Control Group: Hazard Ratio (HR): 0.92 (95% CI 0.71 to 1.19), p = 0.51, Log Rank

Population analysed: A number of 671 new patients with peritoneal dialysis (PD), peritonitis-free, aged 18 years or more, and able to perform PD without assistance were randomized to a control group and a retraining group. Participant who stopped PD treatment due to causes other than peritonitis were managed according to the intention-to-treat principle.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study participants were included from 18 Jan 2010 to 31 Dec 2014. They were followed up to 3 years. The study ended on 31 Dec 2015. No adverse events were reported in this study, which compared the number of peritonitis episodes which occurred in subjects with peritoneal dialysis who were given extra training in performing peritoneal dialysis and those who who were treated according the ordinary routines.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The Follow-up Group	0 of 340 (0%)	0 of 340 (0%)	27 of 340
Control Group	0 of 331 (0%)	0 of 331 (0%)	29 of 331

Limitations and caveats (from the sponsor): The limitations of the study mainly concerns its low power. The power calculation was based on a discontinuation rate of 30% of the participants after one year, However, 40% of the participants had left the study at that time. The power was also weakened by the fact that the recruitment to the study was slower than anticipated, and the final number of randomized participants was only 89% (671 0f 750) of the target, despite the fact that the inclusion time was extended from 2 years to 5 years.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Susanne Ljungman, Prof. emer. study director

Department of Nephrology, Sahlgrenska University Hospital, Gothenburg, Sweden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Retraining in people with Kidney Failure, Chronic and Peritoneal Dialysis-associated Peritonitis, run by Sahlgrenska University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to the First Dialysis-associated Peritonitis Episode in the Retraining Group and the Control Group (time frame: Participants were followed from 1 month after PD start (time of randomization) up to a maximum of 36 months after start of peritoneal dialysis, i.e. to maximally 35 months after randomization. Time to first peritonitis was calculated for each participant.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01293799.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.