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Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

Primary Purpose

End-stage Renal Disease, Renal Failure

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Tenckhoff catheter
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Prince of Wales Hospital, Chinese University of Hong Kong
  • Alice Ho Miu Ling Nethersole Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Straight Tenckhoff catheter

Coiled Tenckhoff catheter

Arm Description

Tenckhoff catheter with straight intra-abdominal part

Tenckhoff catheter with coiled intra-abdominal part

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to catheter dysfunction requiring intervention
see above
Dialysis catheter migration with dysfunction
Dialysis catheter tip located above the pelvic brim on the abdominal radiograph
Infusion pain
Patient will be questioned on infusion pain around one month after starting peritoneal dialysis
Risk of peritonitis
Technique failure
Peritoneal dialysis catheter survival

Full Information

First Posted
June 19, 2015
Last Updated
January 27, 2021
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02479295
Brief Title
Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients
Official Title
Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease, Renal Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
straight versus coiled Tenckhoff catheters
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Straight Tenckhoff catheter
Arm Type
Active Comparator
Arm Description
Tenckhoff catheter with straight intra-abdominal part
Arm Title
Coiled Tenckhoff catheter
Arm Type
Active Comparator
Arm Description
Tenckhoff catheter with coiled intra-abdominal part
Intervention Type
Device
Intervention Name(s)
Tenckhoff catheter
Other Intervention Name(s)
peritoneal dialysis catheter
Intervention Description
Peritoneal dialysis catheters for long term use
Primary Outcome Measure Information:
Title
Incidence of catheter dysfunction that requires intervention
Description
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
Time Frame
One year
Secondary Outcome Measure Information:
Title
Time to catheter dysfunction requiring intervention
Description
see above
Time Frame
One year
Title
Dialysis catheter migration with dysfunction
Description
Dialysis catheter tip located above the pelvic brim on the abdominal radiograph
Time Frame
One year
Title
Infusion pain
Description
Patient will be questioned on infusion pain around one month after starting peritoneal dialysis
Time Frame
One month
Title
Risk of peritonitis
Time Frame
One year
Title
Technique failure
Time Frame
One year
Title
Peritoneal dialysis catheter survival
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Ming Chow, MBChB, FRCP
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital, Chinese University of Hong Kong
City
Shatin
State/Province
New Territories
ZIP/Postal Code
SAR
Country
Hong Kong
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
31445925
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.
Results Reference
derived

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Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

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