Condition category
Urological and Genital Diseases
Date applied
02/03/2015
Date assigned
10/03/2015
Last edited
09/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vanessa Banin

ORCID ID

Contact details

Distrito de Rubião Junior
Botucatu
18609363
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

Study hypothesis

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

Local Ethics Committee in research, 06/04/2013

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Permanent transfer to haemodialysis

Secondary outcome measures

1. Translocations
2. Peritonitis
3. Infections of exit site

Overall trial start date

01/07/2013

Overall trial end date

01/07/2017

Reason abandoned

Eligibility

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.

Participant type

Patient

Age group

Adult

Gender

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.

Participant exclusion criteria

1. Loss to follow-up
2. Recovery of renal function
3. Renal transplantation
4. Death
5. Change elective of method of dialysis

Recruitment start date

01/07/2013

Recruitment end date

01/12/2016

Locations

Countries of recruitment

Brazil

Trial participating centre

Nephrology Service of the Hospital das Clinicas de Botucatu - UNESP
District of Rubião Junior
Botucatu
18609363
Brazil

Sponsor information

Organisation

University UNESP Botucatu

Sponsor details

Distict of Rubião Junior
Botucatu
18609363
Brazil

Sponsor type

University/education

Website

www.fmb.unesp.br

Funders

Funder type

Not defined

Funder name

investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes