Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

January 27, 2021 updated by: Chow Kai Ming, Chinese University of Hong Kong

Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis

This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters, however, are unclear. The investigators design an adequately powered randomized controlled study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that they would need to enroll 132 incident peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 7% and 15% in the primary endpoint of catheter dysfunction requiring intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of the present study is to evaluate the a priori hypothesis that straight peritoneal dialysis catheters would improve the treatment outcomes of peritoneal dialysis. The early and late catheter complications, as well as catheter survival, will be compared between peritoneal dialysis patients who are randomized to straight and coiled Tenckhoff catheters.

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Tai Po, Hong Kong
        • Alice Ho Miu Ling Nethersole Hospital
    • New Territories
      • Shatin, New Territories, Hong Kong, SAR
        • Prince of Wales Hospital, Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • requires dialysis catheter insertion for maintenance peritoneal dialysis
  • aged 18 or older
  • willingness to give written consent and comply with the study protocol

Exclusion Criteria:

  • known contraindication to peritoneal dialysis
  • participation in another interventional study within last 30 days of randomization
  • history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the dialysis procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Straight Tenckhoff catheter
Tenckhoff catheter with straight intra-abdominal part
Device: Tenckhoff catheter
Peritoneal dialysis catheters for long term use
Other Names:
  • peritoneal dialysis catheter
Active Comparator: Coiled Tenckhoff catheter
Tenckhoff catheter with coiled intra-abdominal part
Device: Tenckhoff catheter
Peritoneal dialysis catheters for long term use
Other Names:
  • peritoneal dialysis catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of catheter dysfunction that requires intervention
Time Frame: One year
Catheter dysfunction refers to drainage failure, as defined by the inability to drain peritoneal dialysate effluent reliably within 45 minutes. Intervention includes catheter repositioning or reinsertion, either by open surgical method or laparoscopically
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to catheter dysfunction requiring intervention
Time Frame: One year
see above
One year
Dialysis catheter migration with dysfunction
Time Frame: One year
Dialysis catheter tip located above the pelvic brim on the abdominal radiograph
One year
Infusion pain
Time Frame: One month
Patient will be questioned on infusion pain around one month after starting peritoneal dialysis
One month
Risk of peritonitis
Time Frame: One year
One year
Technique failure
Time Frame: One year
One year
Peritoneal dialysis catheter survival
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Kai Ming Chow, MBChB, FRCP, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

September 1, 2019

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015.197-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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