The Arteriovenous Vascular (AV) ACCESS Trial

Description

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

Conditions

End-Stage Kidney Disease, Hemodialysis Complication

Talk to us

Study Overview

On this page

Study Details

Study overview

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

A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis

The Arteriovenous Vascular (AV) ACCESS Trial

Condition
End-Stage Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham School of Medicine, Birmingham, Alabama, United States, 35487

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Baltimore

Johns Hopkins School of Medicine, Baltimore, Maryland, United States, 21205

Winston-Salem

Atrium Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States, 27157

Greenville

Prisma Health Upstate, Greenville, South Carolina, United States, 29601

Knoxville

University of Tennessee Medical Center at Knoxville, Knoxville, Tennessee, United States, 37920

Madison

University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, United States, 53726

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 the time 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 arteriovenous access, deemed by the treating healthcare providers
  • * Native vasculature deemed preoperatively to be suitable for surgical creation of either 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
  • * Severe cardiac disease defined as presence of either of the following three conditions: 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 of planned study access creation, unless corrected prior to randomization
  • * Planned arteriovenous fistula creation by means other than suture or vascular anastomotic 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 participating centers 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 good candidate for study participation.

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Mariana Murea, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Health Sciences

Matthew P Goldman, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Michael Allon, MD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2027-08-31