Dialysis Catheter Comparative Clinical Trial

Not Applicable

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
First Catheter Induced Complication	245 days	% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

Secondary Outcome Measures

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

Locations (13): Nephrology Associates, P.C.
🇺🇸
Birmingham, Alabama, United States
Southwest Kidney Institute
🇺🇸
Phoenix, Arizona, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
SUNY Stony Brook Medical Center
🇺🇸
Stony Brook, New York, United States
Eastern Nephrology Associates
🇺🇸
New Bern, North Carolina, United States
Boice-Willis Clinic
🇺🇸
Rocky Mount, North Carolina, United States
Dialysis Access Group of Wake Forest University, LLC
🇺🇸
Winston-Salem, North Carolina, United States
Toledo Hospital
🇺🇸
Toledo, Ohio, United States
Temple University Hospital
🇺🇸
Philadelphia, Pennsylvania, United States
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Nephrology Associates, P.C.
🇺🇸Birmingham, Alabama, United States