Clinical trial NCT00526123: Dialysis Catheter Comparative Clinical Trial
Official title: A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Keywords: Dialysis
Dialysis Catheter
Kidney Disease
Dialysis Clinic
Chronic Catheter
Catheter
Kidney
Lead sponsor: Tyco Healthcare Group
Sponsor class: INDUSTRY
First posted: 2007-09-06
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 outcomes:
measure: First Catheter Induced Complication
timeFrame: 30 days
measure: First Catheter Induced Complication
timeFrame: 60 days
measure: First Catheter Induced Complication
timeFrame: 245 days
Secondary outcomes:
measure: Inadequate Flow Rates Requiring Surgical/Radiological Intervention
timeFrame: 35 weeks
measure: Average Number of Line Reversals Per Subject
timeFrame: 35 Weeks
measure: Frequency of Clinician Interventions for Catheter Malfunction and Infection
timeFrame: 35 Weeks
measure: Primary Failure Rate
timeFrame: First dialysis session with study catheter
measure: Reliability of the Catheter
timeFrame: 35 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Nephrology Associates, P.C.
state: Alabama
city: Phoenix
country: United States
facility: Southwest Kidney Institute
state: Arizona
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Stony Brook
country: United States
facility: SUNY Stony Brook Medical Center
state: New York
city: Greenville
country: United States
facility: Eastern Nephrology Associates
state: North Carolina
city: New Bern
country: United States
facility: Eastern Nephrology Associates
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice-Willis Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Dialysis Access Group of Wake Forest University, LLC
state: North Carolina
city: Toledo
country: United States
facility: Toledo Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Nephrology Associates - Lankenau Hospital
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Nephrology Associates
state: South Carolina
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
name: Klemens B Meyer, MD
role: PRINCIPAL_INVESTIGATOR
References: