The Arteriovenous Vascular (AV) ACCESS Trial

Last updated: February 24, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

surgical intervention for creation of a fistula

AV graft

Clinical Study ID

NCT04646226
IRB00069593
1R01AG071803-01
  • Ages > 60
  • All Genders

Study Summary

This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 60 years or older

  • End-stage kidney disease on hemodialysis via a central venous catheter

  • Hemodialysis is the long-term modality of treatment for end-stage kidney disease

  • Central venous catheter is the sole vascular access used for hemodialysis at thetime of referral for arteriovenous access creation

  • Referred by patient's nephrologist for placement of arteriovenous access

  • At least one of the following comorbid conditions: cardiovascular disease,peripheral vascular disease, and/or diabetes mellitus

  • Medically and surgically eligible to undergo surgical placement of an arteriovenousaccess, deemed by the treating healthcare providers

  • Native vasculature deemed preoperatively to be suitable for surgical creation ofeither type of arteriovenous access (arteriovenous fistula or arteriovenous graft)in the opinion of the surgeon

  • Patient agreed to study participation and signed the informed consent

Exclusion

Exclusion Criteria:

  • Severe cardiac disease defined as presence of either of the following threeconditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant,or ventricular assist device

  • Known or suspected central vein stenosis or vascular obstruction on the side ofplanned study access creation, unless corrected prior to randomization

  • Planned arteriovenous fistula creation by means other than suture or vascularanastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)

  • Anticipated kidney transplant within 12 months

  • Anticipated conversion to peritoneal dialysis within 12 months

  • Anticipated transfer of nephrology care to a clinic outside the study participatingcenters within 12 months

  • Anticipated non-compliance with medical care based on physician judgment

  • A condition in which, in the opinion of the site PI renders the patient not a goodcandidate for study participation.

Study Design

Total Participants: 103
Treatment Group(s): 2
Primary Treatment: surgical intervention for creation of a fistula
Phase:
Study Start date:
August 18, 2022
Estimated Completion Date:
August 31, 2027

Study Description

This study will determine the effects of arteriovenous (AV) fistula versus AV graft vascular access strategy on the rate of catheter-free dialysis days and access-related infections - costs associated with the dialysis vascular access - patient-reported satisfaction with different processes of vascular access care (catheter, fistula, or graft) - and the relationship between preoperative functional status and incidence of fistula or graft maturation failure

Connect with a study center

  • University of Alabama at Birmingham School of Medicine

    Birmingham, Alabama 35487
    United States

    Active - Recruiting

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • Johns Hopkins School of Medicine

    Baltimore, Maryland 21205
    United States

    Terminated

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Atrium Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Cleveland Clinic Glickman Urological and Kidney Institute

    Cleveland, Ohio 44125
    United States

    Site Not Available

  • Prisma Health Upstate

    Greenville, South Carolina 29601
    United States

    Active - Recruiting

  • University of Tennessee Medical Center at Knoxville

    Knoxville, Tennessee 37920
    United States

    Active - Recruiting

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin 53726
    United States

    Active - Recruiting

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