Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

Renal Failure Clinical Trial

Official title:

Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479295
• Other study ID #: 2015.197-T
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: September 1, 2019

Study information

• Verified date: January 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: September 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic
• Renal Failure

Intervention

Device:
• Tenckhoff catheter
Peritoneal dialysis catheters for long term use

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital, Chinese University of Hong Kong	Shatin	New Territories
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Tai Po

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of catheter dysfunction that requires intervention	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	Time to catheter dysfunction requiring intervention	see above	One year
Secondary	Dialysis catheter migration with dysfunction	Dialysis catheter tip located above the pelvic brim on the abdominal radiograph	One year
Secondary	Infusion pain	Patient will be questioned on infusion pain around one month after starting peritoneal dialysis	One month
Secondary	Risk of peritonitis		One year
Secondary	Technique failure		One year
Secondary	Peritoneal dialysis catheter survival		One year