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Clinical Trials/NCT03523260
NCT03523260WithdrawnNot Applicable

High-Flow Hemodialysis Catheters Placed Through the Left Internal Jugular Approach (R12-022)

University of Alabama at Birmingham1 site in 1 countryStarted: August 27, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Locations
1
Primary Endpoint
Complication rate

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Tunneled dialysis Split-tip catheter

Active Comparator

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

Intervention: Tunneled dialysis catheter placement. (Device)

Tunneled dialysis Step-tip catheter

Active Comparator

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

Intervention: Tunneled dialysis catheter placement. (Device)

Tunneled dialysis Symmetric tip catheter

Active Comparator

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

Intervention: Tunneled dialysis catheter placement. (Device)

Outcomes

Primary Outcomes

Complication rate

Time Frame: 1 month

1 month complication rate of left internal jugular vein dialysis catheters

Secondary Outcomes

  • Complication rate(6 months)
  • Catheter dysfunction(6 months)
  • Catheter dysfunction(3 months)
  • Catheter dysfunction(1 months)
  • Complication rate(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Husameddin M El Khudari

Interventional Radiology

University of Alabama at Birmingham

Study Sites (1)

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