Plain English Summary
Background and study aims
Dialysis is a form of treatment that has been developed to take over the work of the kidney during end-stage kidney failure. It filters the blood, removing harmful waste, excess salt and excess water. There are two types of dialysis: haemodialysis and peritoneal dialysis (PD). Unlike haemodialysis, where the blood is filtered by an artificial membrane outside the body, peritoneal dialysis involves filtering the blood through the peritoneum, a thin membrane lining the outside of the abdominal organs. It works via the running of a dialysis fluid in and out of the peritoneal cavity, through a tube called a Tenckhoff Catheter. In order for the treatment to be successful, it is essential to obtain a continuous and secure access to the peritoneal cavity. Despite improvements in recent years, translocations and infections are still common and are a major cause for morbidity. More than 20% of PD patients need catheter removal and are permanently transferred to haemodialysis. One factor that could affect the incidence of such complications is the position of the catheter exit site. There is little evidence in the literature that suggest the best location of the exit site in relation to the risk of complications. This study will investigate whether the position of the catheter exit site influences the number of translocations and infections associated with peritoneal dialysis.
Who can participate?
Patients with chronic renal failure, age 18 and over, undergoing PD catheter implantation.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 have their catheter implanted with the exit side down. Those in group 2 have their catheter implanted with the exit site up. The patients are then followed for one year and the following outcomes reported: translocations, peritonitis, infections of exit site and permanent transfer to haemodialysis.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Nephrology Service of the Hospital das Clinicas de Botucatu – UNESP (Brazil)
When is the study starting and how long is it expected to run for?
July 2013 to July 2017
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Vanessa Banin
Influence of the catheter exit site position on the risk of mechanical and infectious complications and technique survival in peritoneal dialysis patients: a randomised controlled trial
Catheter exit site position influences translocations rate and infectious complications associated with peritoneal dialysis, and also can affect the survival of the method.
Local Ethics Committee in research, 06/04/2013
Randomised controlled trial
Primary study design
Secondary study design
Randomised controlled trial
Patient information sheet
Patients with chronic renal failure over 18 years of age and peritoneal dialysis incidents.
Implant of peritoneal dialysis catheter being executed in two different ways:
1. Catheter implantation with exit site down
2. Catheter implantation with exit site up
Primary outcome measure
Permanent transfer to haemodialysis
Secondary outcome measures
3. Infections of exit site
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Patients with chronic renal failure over 18 years of age and peritoneal dialysis incidents, followed by the Nephrology Service of the Hospital das Clinicas de Botucatu - UNESP - Brazil.
Target number of participants
To provide a statistical power of 80 %, with Beta error of 20% and identify a minimum difference of 40% between the two groups regarding the frequency of translocations, are required 30 patients in each group, a total of 60 patients.
Participant exclusion criteria
1. Loss to follow-up
2. Recovery of renal function
3. Renal transplantation
5. Change elective of method of dialysis
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Nephrology Service of the Hospital das Clinicas de Botucatu - UNESP
District of Rubião Junior
University UNESP Botucatu
Distict of Rubião Junior
investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Intention to publish date
Participant level data
Basic results (scientific)