Dialysis Catheter Comparative Clinical Trial

Study Overview
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Brief Summary
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The purpose of this clinical trial is to compare the longevity of two dialysis catheters.

Detailed Description
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This study is a multi-center, randomized, prospective, open-label, clinical study comparing a conventional split-tip catheter and a symmetric tip catheter in subjects undergoing hemodialysis.

Official Title
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A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: Symmetric Tip Catheter
* Device: Conventional Split-tip Catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be 18 years of age or older. Subject must meet labeled indication for hemodialysis. Subject must have End Stage Renal Disease (ESRD). Subject must have a patent right or left internal jugular vein. Subject treatment plan must require chronic hemodialysis treatments 3 times per week for a minimum of 6 weeks. Subject must give written informed consent. Exclusion Criteria: Subjects who are concurrently enrolled in any Randomized Clinical Trial (RCT) or those that may enroll in a RCT during the course of the study, or subjects who have been previously randomized into this clinical study. Subjects with active infection at the time of study enrollment. Subjects with a known sensitivity to heparin, or previous incidence of heparin-induced thrombocytopenia. Subjects with uncontrolled abnormal coagulation parameters and are at additional risk for clotting or excessive bleeding. Subjects who are known or suspected to be pregnant at the time of study enrollment or plan to get pregnant during the study period. Subjects for whom performing dialysis at flow rates up to 450 mL/min would be contraindicated for any reason. Subject unable or unwilling to commit to follow-up visits and study procedures throughout the course of the study. Subjects who, in the opinion of the Investigators, are not appropriate candidates for the study based upon current or past medical history, or negative past experience with either of the study catheters.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>symmetric tip catheter | Device: Symmetric Tip Catheter<br>* Dialysis catheter<br>|
| Active Comparator: 2<br>conventional split-tip catheter | Device: Conventional Split-tip Catheter<br>* Dialysis Catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 30 days | 
| First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 60 days | 
| First Catheter Induced Complication | % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame. | 245 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inadequate Flow Rates Requiring Surgical/Radiological Intervention | Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'. | 35 weeks | 
| Average Number of Line Reversals Per Subject | Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments | 35 Weeks | 
| Frequency of Clinician Interventions for Catheter Malfunction and Infection | Average number of times clinician intervention was required for either catheter malfunction or infection | 35 Weeks | 
| Primary Failure Rate | The percentage of catheters unable to deliver adequate blood flow of at least 300 mL/min for at least 50% of measurements during the first attempted dialysis session. | First dialysis session with study catheter | 
| Reliability of the Catheter | Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min. | 35 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Dialysis Catheter, Kidney Disease, Dialysis Clinic, Chronic Catheter, Catheter, Kidney