Comparison of High-Flow Hemodialysis Catheters Placed From the Left Internal Jugular Vein(R12-022)

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03523260
Collaborator
(none)
0
1
3
76.8
0

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Tunneled dialysis catheter placement.
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)
Actual Study Start Date :
Aug 27, 2013
Actual Primary Completion Date :
Jan 22, 2020
Actual Study Completion Date :
Jan 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Tunneled dialysis Split-tip catheter

High-flow tunneled Split-tip catheter for hemodialysis will be inserted by standard interventional technique

Device: Tunneled dialysis catheter placement.
Placement of high-flow tunneled catheter for hemodialysis

Active Comparator: Tunneled dialysis Step-tip catheter

High-flow tunneled Step-tip catheter for hemodialysis will be inserted by standard interventional technique

Device: Tunneled dialysis catheter placement.
Placement of high-flow tunneled catheter for hemodialysis

Active Comparator: Tunneled dialysis Symmetric tip catheter

High-flow tunneled Symmetric tip catheter for hemodialysis will be inserted by standard interventional technique

Device: Tunneled dialysis catheter placement.
Placement of high-flow tunneled catheter for hemodialysis

Outcome Measures

Primary Outcome Measures

  1. Complication rate [1 month]

    1 month complication rate of left internal jugular vein dialysis catheters

Secondary Outcome Measures

  1. Catheter dysfunction [1 months]

    1 month complication rate of left internal jugular vein dialysis catheters

  2. Catheter dysfunction [3 months]

    3 months complication rate of left internal jugular vein dialysis catheters

  3. Catheter dysfunction [6 months]

    6 months complication rate of left internal jugular vein dialysis catheters

  4. Complication rate [3 months]

    3 months complication rate of left internal jugular vein dialysis catheters

  5. Complication rate [6 months]

    6 months complication rate of left internal jugular vein dialysis catheters

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Akabama at Birmingham Birmingham Alabama United States 35249

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Husameddin M El Khudari, Interventional Radiology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT03523260
Other Study ID Numbers:
  • IRB-130430002
First Posted:
May 14, 2018
Last Update Posted:
May 10, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2021