Clinical trial NCT02479295: Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients
Official title: Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End-stage Renal Disease
Renal Failure
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: straight versus coiled Tenckhoff catheters
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of catheter dysfunction that requires intervention
timeFrame: One year
Secondary outcomes:
measure: Time to catheter dysfunction requiring intervention
timeFrame: One year
measure: Dialysis catheter migration with dysfunction
timeFrame: One year
measure: Infusion pain
timeFrame: One month
measure: Risk of peritonitis
timeFrame: One year
measure: Technique failure
timeFrame: One year
measure: Peritoneal dialysis catheter survival
timeFrame: One year
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital, Chinese University of Hong Kong
state: New Territories
city: Tai Po
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Kai Ming Chow, MBChB, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chow KM, Wong SSM, Ng JKC, Cheng YL, Leung CB, Pang WF, Fung WWS, Szeto CC, Li PKT. Straight Versus Coiled Peritoneal Dialysis Catheters: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):39-44. doi: 10.1053/j.ajkd.2019.05.024. Epub 2019 Aug 21.