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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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Prince of Wales Hospital, Chinese University of Hong Kong
Shatin, New Territories, Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Tai Po, Hong Kong
Start Date
June 1, 2015
Primary Completion Date
January 1, 2019
Completion Date
September 1, 2019
Last Updated
January 28, 2021
306
ACTUAL participants
Tenckhoff catheter
DEVICE
Lead Sponsor
Chinese University of Hong Kong
NCT04634916
NCT06933472
Data Source & Attribution
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