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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523260
Recruitment Status : Recruiting
First Posted : May 14, 2018
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
Husameddin M El Khudari, University of Alabama at Birmingham

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
End Stage Renal Disease on Dialysis (Diagnosis) Device: Tunneled dialysis catheter placement. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 : August 27, 2013
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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




Primary Outcome Measures :
  1. Complication rate [ Time Frame: 1 month ]
    1 month complication rate of left internal jugular vein dialysis catheters


Secondary Outcome Measures :
  1. Catheter dysfunction [ Time Frame: 1 months ]
    1 month complication rate of left internal jugular vein dialysis catheters

  2. Catheter dysfunction [ Time Frame: 3 months ]
    3 months complication rate of left internal jugular vein dialysis catheters

  3. Catheter dysfunction [ Time Frame: 6 months ]
    6 months complication rate of left internal jugular vein dialysis catheters

  4. Complication rate [ Time Frame: 3 months ]
    3 months complication rate of left internal jugular vein dialysis catheters

  5. Complication rate [ Time Frame: 6 months ]
    6 months complication rate of left internal jugular vein dialysis catheters



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523260


Contacts
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Contact: Ahmed M Kamel Abdel Aal, MD 205-975-4850 akamel@uabmc.edu
Contact: Marianne Vetrano, RN 205-934-4080 mvetrano@uabmc.edu

Locations
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United States, Alabama
University of Akabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Ahmed M. Kamel Abdel Aal, MD    205-975-4850    akamel@uabmc.edu   
Contact: April Riddle, RT    205-9346504    ariddle@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Ahmed M. Kamel Abdel Aal, MD University of Alabama at Birmingham
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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    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency