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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-27

Study Completion Date

2020-01-22

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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End Stage Renal Disease on Dialysis (Diagnosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Tunneled dialysis Split-tip catheter

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

Group Type ACTIVE_COMPARATOR

Tunneled dialysis catheter placement.

Intervention Type DEVICE

Placement of high-flow tunneled catheter for hemodialysis

Tunneled dialysis Step-tip catheter

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

Group Type ACTIVE_COMPARATOR

Tunneled dialysis catheter placement.

Intervention Type DEVICE

Placement of high-flow tunneled catheter for hemodialysis

Tunneled dialysis Symmetric tip catheter

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

Group Type ACTIVE_COMPARATOR

Tunneled dialysis catheter placement.

Intervention Type DEVICE

Placement of high-flow tunneled catheter for hemodialysis

Interventions

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Tunneled dialysis catheter placement.

Placement of high-flow tunneled catheter for hemodialysis

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No