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Completed

NCT Number: NCT00526123

Dialysis Catheter Comparative Clinical Trial

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephrology Associates, P.C., Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symmetric Tip Catheter

Device

Dialysis catheter

Conventional Split-tip Catheter

Device

Dialysis Catheter

Primary outcomes

  1. First Catheter Induced Complication

    Time frame: 30 days

    % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

  2. First Catheter Induced Complication

    Time frame: 60 days

    % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

  3. First Catheter Induced Complication

    Time frame: 245 days

    % of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.

Secondary outcomes

  1. Inadequate Flow Rates Requiring Surgical/Radiological Intervention

    Time frame: 35 weeks

    Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.

  2. Average Number of Line Reversals Per Subject

    Time frame: 35 Weeks

    Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments

  3. Frequency of Clinician Interventions for Catheter Malfunction and Infection

    Time frame: 35 Weeks

    Average number of times clinician intervention was required for either catheter malfunction or infection

  4. Primary Failure Rate

    Time frame: 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.

  5. Reliability of the Catheter

    Time frame: 35 Weeks

    Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.

Sponsors and collaborators

Lead sponsor

Tyco Healthcare Group

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Sep 6, 2007
Registry last updated
Jan 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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