Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

The Chinese University of Hong Kong

Status: Completed

Conditions: Renal Failure; End-stage Renal Disease

Treatments: Device: Tenckhoff catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02479295

2015.197-T

Details and patient eligibility

About

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.

Full 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.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

Straight Tenckhoff catheter

Active Comparator group

Description:

Tenckhoff catheter with straight intra-abdominal part

Treatment:

Device: Tenckhoff catheter

Coiled Tenckhoff catheter

Active Comparator group

Description:

Tenckhoff catheter with coiled intra-abdominal part

Treatment:

Device: Tenckhoff catheter