Dialysis Catheter Comparative Clinical Trial

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

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

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: Symmetric Tip Catheter; Device: Conventional Split-tip Catheter

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.

• Study Type: Interventional
• Enrollment (Actual): 599
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • Nephrology Associates, P.C.
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Southwest Kidney Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • New York
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook Medical Center
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Eastern Nephrology Associates
    • New Bern, North Carolina, United States, 28562
      • Eastern Nephrology Associates
    • Rocky Mount, North Carolina, United States, 27804
      • Boice-Willis Clinic
    • Winston-Salem, North Carolina, United States, 27101
      • Dialysis Access Group of Wake Forest University, LLC
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Toledo Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Wynnewood, Pennsylvania, United States, 19096
      • Nephrology Associates - Lankenau Hospital
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Columbia Nephrology Associates
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tyco Healthcare Group
• Investigators: Principal Investigator: Klemens B Meyer, MD

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: September 5, 2007
• First Submitted That Met QC Criteria: September 5, 2007
• First Posted (Estimate): September 6, 2007

Study Record Updates

• Last Update Posted (Estimate): January 7, 2013
• Last Update Submitted That Met QC Criteria: January 3, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Dialysis; Kidney Disease; Kidney; Catheter; Dialysis Catheter; Dialysis Clinic; Chronic Catheter
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 341.26