Prevention of Peritonitis in Peritoneal Dialysis (PEPS)

• 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.
  
  

• 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.
  
  

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.