NCT02479295

Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End-stage Renal Disease
• Renal Failure

Interventions

Type	Name	Description
DEVICE	Tenckhoff catheter	Peritoneal dialysis catheters for long term use

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-01-01
• Completion: 2019-09-01
• First posted: 2015-06-24
• Last updated: 2021-01-28

Locations

2 sites across 1 country: Hong Kong