Straight Versus Coiled Peritoneal Dialysis Catheter for Peritoneal Dialysis Patients

Study Overview
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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.

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.

Official Title
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Randomized Controlled Trial of Straight Versus Coiled Peritoneal Dialysis

Conditions
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End-stage Renal Disease, Renal Failure

Intervention / Treatment
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* Device: Tenckhoff catheter


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: straight versus coiled Tenckhoff catheters
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Straight Tenckhoff catheter<br>Tenckhoff catheter with straight intra-abdominal part | Device: Tenckhoff catheter<br>* Peritoneal dialysis catheters for long term use<br>* Other names: peritoneal dialysis catheter;|
| Active Comparator: Coiled Tenckhoff catheter<br>Tenckhoff catheter with coiled intra-abdominal part | Device: Tenckhoff catheter<br>* Peritoneal dialysis catheters for long term use<br>* Other names: peritoneal dialysis catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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