The Arteriovenous Vascular (AV) ACCESS Trial

NCT ID: NCT04646226

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-18
• Study Completion Date: 2027-08-31

Brief 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

Detailed 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

Conditions

End-Stage Kidney Disease; Hemodialysis Complication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

fistula surgically placed

Randomized group to have surgically placed fistula for permanent hemodialysis access

Group Type: EXPERIMENTAL

surgical intervention for creation of a fistula

Intervention Type: PROCEDURE

The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)

graft surgically placed

Randomized group to have surgically placed graft for permanent hemodialysis access

Group Type: ACTIVE_COMPARATOR

AV graft

Intervention Type: DEVICE

The purpose of the surgery is to connect a large vein in the arm to a nearby artery indirectly by inserting a graft material (graft surgery)

Interventions

AV graft

The purpose of the surgery is to connect a large vein in the arm to a nearby artery indirectly by inserting a graft material (graft surgery)

Intervention Type: DEVICE

surgical intervention for creation of a fistula

The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)

Intervention Type: PROCEDURE

Eligibility Criteria

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 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariana Murea, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Health Sciences

Matthew P Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Michael Allon, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham School of Medicine

Birmingham, Alabama, United States

UCLA

Los Angeles, California, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Atrium Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Prisma Health Upstate

Greenville, South Carolina, United States

University of Tennessee Medical Center at Knoxville

Knoxville, Tennessee, United States

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Countries

United States

References

Murea M, Gardezi AI, Goldman MP, Hicks CW, Lee T, Middleton JP, Shingarev R, Vachharajani TJ, Woo K, Abdelnour LM, Bennett KM, Geetha D, Kirksey L, Southerland KW, Young CJ, Brown WM, Bahnson J, Chen H, Allon M. Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial. BMC Nephrol. 2023 Feb 24;24(1):43. doi: 10.1186/s12882-023-03086-5.

Reference Type: DERIVED

PMID: 36829135 (View on PubMed)

Other Identifiers

1R01AG071803-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00069593

Identifier Type: -

Identifier Source: org_study_id