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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Withdrawn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
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for End Stage Renal Disease on Dialysis (Diagnosis)

Eligibility Criteria

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

Inclusion Criteria:

  1. Willing and able to provide a written informed consent
  2. 19 years or older
  3. Hemodialysis patient needing high-flow polyurethane tunneled dialysis catheter placement via the left internal jugular vein.
  4. Patent left internal jugular vein.
  5. Able to read and understand English.

Exclusion Criteria:

  1. Previous enrollment in this trial
  2. Patients unable or unwilling to provide informed consent
  3. Prisoners or incarcerated individuals
  4. Women who are pregnant
  5. 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

First Posted
February 7, 2018
Last Updated
May 6, 2021
Sponsor
University of Alabama at Birmingham
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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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