Dialysis Catheter Comparative Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tyco Healthcare Group
ClinicalTrials.gov Identifier:
NCT00526123
First received: September 5, 2007
Last updated: January 3, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
End Stage Renal Disease
Device: Symmetric Tip Catheter
Device: Conventional Split-tip Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label Comparison of the Performance and Longevity of a Split-tip Versus a Symmetric Tip Hemodialysis

Resource links provided by NLM:


Further study details as provided by Tyco Healthcare Group:

Primary Outcome Measures:
  • First Catheter Induced Complication [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

  • First Catheter Induced Complication [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

  • First Catheter Induced Complication [ Time Frame: 245 days ] [ Designated as safety issue: No ]
    % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.


Secondary Outcome Measures:
  • Inadequate Flow Rates Requiring Surgical/Radiological Intervention [ Time Frame: 35 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 35 Weeks ] [ Designated as safety issue: No ]
    Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments

  • Frequency of Clinician Interventions for Catheter Malfunction and Infection [ Time Frame: 35 Weeks ] [ Designated as safety issue: No ]
    Average number of times clinician intervention was required for either catheter malfunction or infection

  • Primary Failure Rate [ Time Frame: First dialysis session with study catheter ] [ Designated as safety issue: No ]
    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 [ Time Frame: 35 Weeks ] [ Designated as safety issue: No ]
    Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.


Enrollment: 599
Study Start Date: September 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526123

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

No publications provided

Responsible Party: Tyco Healthcare Group
ClinicalTrials.gov Identifier: NCT00526123     History of Changes
Other Study ID Numbers: 341.26
Study First Received: September 5, 2007
Results First Received: August 30, 2012
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tyco Healthcare Group:
Dialysis
Dialysis Catheter
Kidney Disease
Dialysis Clinic
Chronic Catheter
Catheter
Kidney

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on August 19, 2014