Dialysis Catheter Comparative Clinical Trial

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00526123
• Other study ID #: 341.26
• Status: Completed
• Phase: N/A
• First received: September 5, 2007
• Last updated: January 3, 2013
• Start date: September 2007
• Est. completion date: August 2011

Study information

• Verified date: January 2013
• Source: Tyco Healthcare Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 599
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Symmetric Tip Catheter
Dialysis catheter
• Conventional Split-tip Catheter
Dialysis Catheter

Locations

Country	Name	City	State
United States	Nephrology Associates, P.C.	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Medical Center	Boston	Massachusetts
United States	Columbia Nephrology Associates	Columbia	South Carolina
United States	Eastern Nephrology Associates	Greenville	North Carolina
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Eastern Nephrology Associates	New Bern	North Carolina
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	Southwest Kidney Institute	Phoenix	Arizona
United States	Boice-Willis Clinic	Rocky Mount	North Carolina
United States	SUNY Stony Brook Medical Center	Stony Brook	New York
United States	Toledo Hospital	Toledo	Ohio
United States	Dialysis Access Group of Wake Forest University, LLC	Winston-Salem	North Carolina
United States	Nephrology Associates - Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Tyco Healthcare Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First Catheter Induced Complication	% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.	30 days	No
Primary	First Catheter Induced Complication	% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.	60 days	No
Primary	First Catheter Induced Complication	% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.	245 days	No
Secondary	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	No
Secondary	Average Number of Line Reversals Per Subject	Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments	35 Weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No