Influence of the catheter exit site position on the risk of mechanical and infectious complications and technique survival in peritoneal dialysis patients.
| ISRCTN | ISRCTN15159688 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15159688 |
| Protocol serial number | N/A |
| Sponsor | University UNESP Botucatu |
| Funder | investigator initiated and funded |
- Submission date
- 02/03/2015
- Registration date
- 10/03/2015
- Last edited
- 09/03/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
Distrito de Rubião Junior
Botucatu
18609363
Brazil
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study objectives | Catheter exit site position influences translocations rate and infectious complications associated with peritoneal dialysis, and also can affect the survival of the method. |
| Ethics approval(s) | Local Ethics Committee in research, 06/04/2013 |
| Health condition(s) or problem(s) studied | Patients with chronic renal failure over 18 years of age and peritoneal dialysis incidents. |
| Intervention | 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 |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Permanent transfer to haemodialysis |
| Key secondary outcome measure(s) |
1. Translocations |
| Completion date | 01/07/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key 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. |
| Key exclusion criteria | 1. Loss to follow-up 2. Recovery of renal function 3. Renal transplantation 4. Death 5. Change elective of method of dialysis |
| Date of first enrolment | 01/07/2013 |
| Date of final enrolment | 01/12/2016 |
Locations
Countries of recruitment
- Brazil
Study participating centre
Botucatu
18609363
Brazil
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan |
