Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2019-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End-stage Renal Disease Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

straight versus coiled Tenckhoff catheters

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Straight Tenckhoff catheter

Tenckhoff catheter with straight intra-abdominal part

Group Type ACTIVE_COMPARATOR

Tenckhoff catheter

Intervention Type DEVICE

Peritoneal dialysis catheters for long term use

Coiled Tenckhoff catheter

Tenckhoff catheter with coiled intra-abdominal part

Group Type ACTIVE_COMPARATOR

Tenckhoff catheter

Intervention Type DEVICE

Peritoneal dialysis catheters for long term use

Interventions

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Tenckhoff catheter

Peritoneal dialysis catheters for long term use

Intervention Type DEVICE

Other Intervention Names

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peritoneal dialysis catheter

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No