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Dialysis Catheter Comparative Clinical Trial

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symmetric Tip Catheter
Conventional Split-tip Catheter
Sponsored by
Tyco Healthcare Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Dialysis, Dialysis Catheter, Kidney Disease, Dialysis Clinic, Chronic Catheter, Catheter, Kidney

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nephrology Associates, P.C.
  • Southwest Kidney Institute
  • Tufts Medical Center
  • Massachusetts General Hospital
  • SUNY Stony Brook Medical Center
  • Eastern Nephrology Associates
  • Eastern Nephrology Associates
  • Boice-Willis Clinic
  • Dialysis Access Group of Wake Forest University, LLC
  • Toledo Hospital
  • Temple University Hospital
  • Nephrology Associates - Lankenau Hospital
  • Columbia Nephrology Associates
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

symmetric tip catheter

conventional split-tip catheter

Outcomes

Primary Outcome Measures

First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
First Catheter Induced Complication
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
First Catheter Induced Complication
% 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
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
Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments
Frequency of Clinician Interventions for Catheter Malfunction and Infection
Average number of times clinician intervention was required for either catheter malfunction or infection
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.
Reliability of the Catheter
Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.

Full Information

First Posted
September 5, 2007
Last Updated
January 3, 2013
Sponsor
Tyco Healthcare Group
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1. Study Identification

Unique Protocol Identification Number
NCT00526123
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tyco Healthcare Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Dialysis, Dialysis Catheter, Kidney Disease, Dialysis Clinic, Chronic Catheter, Catheter, Kidney

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
symmetric tip catheter
Arm Title
2
Arm Type
Active Comparator
Arm Description
conventional split-tip catheter
Intervention Type
Device
Intervention Name(s)
Symmetric Tip Catheter
Intervention Description
Dialysis catheter
Intervention Type
Device
Intervention Name(s)
Conventional Split-tip Catheter
Intervention Description
Dialysis Catheter
Primary Outcome Measure Information:
Title
First Catheter Induced Complication
Description
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time Frame
30 days
Title
First Catheter Induced Complication
Description
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time Frame
60 days
Title
First Catheter Induced Complication
Description
% of participants that did not experience a catheter induced complication at the specified Outcome Measure Time Frame.
Time Frame
245 days
Secondary Outcome Measure Information:
Title
Inadequate Flow Rates Requiring Surgical/Radiological Intervention
Description
Number of events per study group in which the first catheter induced complication was 'inadequate flow requiring surgical/radiological intervention'.
Time Frame
35 weeks
Title
Average Number of Line Reversals Per Subject
Description
Average number of times the dialysis lines were reversed per subject to deliver dialysis treatments
Time Frame
35 Weeks
Title
Frequency of Clinician Interventions for Catheter Malfunction and Infection
Description
Average number of times clinician intervention was required for either catheter malfunction or infection
Time Frame
35 Weeks
Title
Primary Failure Rate
Description
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.
Time Frame
First dialysis session with study catheter
Title
Reliability of the Catheter
Description
Percentage of study visits in which the median blood flow rate was greater than or equal to 300 mL/min.
Time Frame
35 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klemens B Meyer, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology Associates, P.C.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
Southwest Kidney Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
SUNY Stony Brook Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Eastern Nephrology Associates
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Eastern Nephrology Associates
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Boice-Willis Clinic
City
Rocky Mount
State/Province
North Carolina
ZIP/Postal Code
27804
Country
United States
Facility Name
Dialysis Access Group of Wake Forest University, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27101
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Nephrology Associates - Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Columbia Nephrology Associates
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Dialysis Catheter Comparative Clinical Trial

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