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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Withdrawn

Conditions

End Stage Renal Disease on Dialysis (Diagnosis)

Treatments

Device: Tunneled dialysis catheter placement.

Study type

Interventional

Funder types

Other

Identifiers

NCT03523260
IRB-130430002

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

19+ years old

Volunteers

No 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

Trial design

Primary purpose

Device Feasibility

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Tunneled dialysis Split-tip catheter
Active Comparator group
Description:
High-flow tunneled Split-tip catheter for hemodialysis will be inserted by standard interventional technique
Treatment:
Device: Tunneled dialysis catheter placement.
Tunneled dialysis Step-tip catheter
Active Comparator group
Description:
High-flow tunneled Step-tip catheter for hemodialysis will be inserted by standard interventional technique
Treatment:
Device: Tunneled dialysis catheter placement.
Tunneled dialysis Symmetric tip catheter
Active Comparator group
Description:
High-flow tunneled Symmetric tip catheter for hemodialysis will be inserted by standard interventional technique
Treatment:
Device: Tunneled dialysis catheter placement.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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