Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

Not Applicable

Completed

• Conditions: Renal Failure; End-stage Renal Disease
• Interventions: Device: Tenckhoff catheter

• Registration Number: NCT02479295
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

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 Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2015-06-19
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Primary Completion: 2019-01-01
• Study Completion: 2019-09-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Straight Tenckhoff catheter	Tenckhoff catheter	Tenckhoff catheter with straight intra-abdominal part
Coiled Tenckhoff catheter	Tenckhoff catheter	Tenckhoff catheter with coiled intra-abdominal part

Primary Outcome Measures

Name	Time	Method
Incidence of catheter dysfunction that requires intervention	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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Prince of Wales Hospital, Chinese University of Hong Kong; 🇭🇰 Shatin, New Territories, Hong Kong

Alice Ho Miu Ling Nethersole Hospital; 🇭🇰 Tai Po, Hong Kong