Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)
Primary Purpose
End Stage Renal Disease on Dialysis (Diagnosis)
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tunneled dialysis catheter placement.
Sponsored by
About this trial
This is an interventional device feasibility trial for End Stage Renal Disease on Dialysis (Diagnosis)
Eligibility Criteria
Inclusion Criteria:
- Willing and able to provide a written informed consent
- 19 years or older
- Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein.
- Patent left internal jugular vein.
- Able to read and understand English.
Exclusion Criteria:
- Previous enrollment in this trial
- Patients unable or unwilling to provide informed consent
- Prisoners or incarcerated individuals
- Women who are pregnant
- Patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated
Sites / Locations
- University of Akabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Tunneled dialysis Split-tip catheter
Tunneled dialysis Step-tip catheter
Tunneled dialysis Symmetric tip catheter
Arm Description
High-flow tunneled Split-tip catheter for hemodialysis will be inserted by standard interventional technique
High-flow tunneled Step-tip catheter for hemodialysis will be inserted by standard interventional technique
High-flow tunneled Symmetric tip catheter for hemodialysis will be inserted by standard interventional technique
Outcomes
Primary Outcome Measures
Complication rate
1 month complication rate of left internal jugular vein dialysis catheters
Secondary Outcome Measures
Catheter dysfunction
1 month complication rate of left internal jugular vein dialysis catheters
Catheter dysfunction
3 months complication rate of left internal jugular vein dialysis catheters
Catheter dysfunction
6 months complication rate of left internal jugular vein dialysis catheters
Complication rate
3 months complication rate of left internal jugular vein dialysis catheters
Complication rate
6 months complication rate of left internal jugular vein dialysis catheters
Full Information
NCT ID
NCT03523260
First Posted
February 7, 2018
Last Updated
May 6, 2021
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03523260
Brief Title
Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)
Official Title
High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Never funded
Study Start Date
August 27, 2013 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. This study will review and compare the complication rate and function of the three catheter designs.
Detailed Description
The patient population for this study is individuals requiring high-flow polyurethane tunneled dialysis catheters (TDC) for hemodialysis access. The primary objective of this study is to compare outcomes of participants who undergo left internal jugular placement of a split-tip versus a step-tip versus symmetric tip catheter. Participants will be randomized to receive a split-tip, step-tip or symmetric tip catheter in a 1:1:1 ratio. All participants will be followed per their referring physician's standard of care. Information regarding any patient complications will be obtained from Dr. Allon's dialysis patient database (Vascular Access in Hemodialysis Patients, IRB # X980813005). This study will review and compare the complication rate and function of the three catheter designs. There are no studies to our knowledge that compared catheter designs placed specifically via the left internal jugular vein. The investigators hypothesize that because the left internal jugular vein is anatomically more complex than the right one, tunneled dialysis catheters with split-tip design may perform sub-optimally, compared to step-tip and symmetric tip designs, when placed via the left internal jugular vein. If this hypothesis is true, the results of the study may influence future clinical practice and reduce the rates of replacement of catheters placed through the left internal jugular vein, resulting in better patient care and significant cost-savings.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis (Diagnosis)
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tunneled dialysis Split-tip catheter
Arm Type
Active Comparator
Arm Description
High-flow tunneled Split-tip catheter for hemodialysis will be inserted by standard interventional technique
Arm Title
Tunneled dialysis Step-tip catheter
Arm Type
Active Comparator
Arm Description
High-flow tunneled Step-tip catheter for hemodialysis will be inserted by standard interventional technique
Arm Title
Tunneled dialysis Symmetric tip catheter
Arm Type
Active Comparator
Arm Description
High-flow tunneled Symmetric tip catheter for hemodialysis will be inserted by standard interventional technique
Intervention Type
Device
Intervention Name(s)
Tunneled dialysis catheter placement.
Intervention Description
Placement of high-flow tunneled catheter for hemodialysis
Primary Outcome Measure Information:
Title
Complication rate
Description
1 month complication rate of left internal jugular vein dialysis catheters
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Catheter dysfunction
Description
1 month complication rate of left internal jugular vein dialysis catheters
Time Frame
1 months
Title
Catheter dysfunction
Description
3 months complication rate of left internal jugular vein dialysis catheters
Time Frame
3 months
Title
Catheter dysfunction
Description
6 months complication rate of left internal jugular vein dialysis catheters
Time Frame
6 months
Title
Complication rate
Description
3 months complication rate of left internal jugular vein dialysis catheters
Time Frame
3 months
Title
Complication rate
Description
6 months complication rate of left internal jugular vein dialysis catheters
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide a written informed consent
19 years or older
Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein.
Patent left internal jugular vein.
Able to read and understand English.
Exclusion Criteria:
Previous enrollment in this trial
Patients unable or unwilling to provide informed consent
Prisoners or incarcerated individuals
Women who are pregnant
Patients in whom the left internal jugular vein is occluded or catheter placement is otherwise contraindicated
Facility Information:
Facility Name
University of Akabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)
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