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
Secondary identifying numbers	N/A

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Dr Vanessa Banin
Scientific

Distrito de Rubião Junior
Botucatu
18609363
Brazil

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	Permanent transfer to haemodialysis
Secondary outcome measures	1. Translocations 2. Peritonitis 3. Infections of exit site
Overall study start date	01/07/2013
Completion date	01/07/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
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.
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

Nephrology Service of the Hospital das Clinicas de Botucatu - UNESP

District of Rubião Junior
Botucatu
18609363
Brazil

Sponsor information

University UNESP Botucatu
University/education

Distict of Rubião Junior
Botucatu
18609363
Brazil

Website	www.fmb.unesp.br
"ROR"	https://ror.org/00987cb86

Funders

Funder type

Not defined

investigator initiated and funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan
IPD sharing plan