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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: End Stage Renal Disease on Dialysis (Diagnosis)
• Intervention / Treatment: Device: Tunneled dialysis catheter placement.

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Akabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	1 month complication rate of left internal jugular vein dialysis catheters	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Catheter dysfunction	1 month complication rate of left internal jugular vein dialysis catheters	1 months
Catheter dysfunction	3 months complication rate of left internal jugular vein dialysis catheters	3 months
Catheter dysfunction	6 months complication rate of left internal jugular vein dialysis catheters	6 months
Complication rate	3 months complication rate of left internal jugular vein dialysis catheters	3 months
Complication rate	6 months complication rate of left internal jugular vein dialysis catheters	6 months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2013
• Primary Completion (Actual): January 22, 2020
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: IRB-130430002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes