The Arteriovenous Vascular (AV) ACCESS Trial

Wake Forest University (WFU)

Status: Enrolling

Conditions: Hemodialysis Complication; End-Stage Kidney Disease

Treatments: Device: AV graft; Procedure: surgical intervention for creation of a fistula

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04646226

IRB00069593

1R01AG071803-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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

Enrollment: 103 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

fistula surgically placed

Experimental group

Description:

Randomized group to have surgically placed fistula for permanent hemodialysis access

Treatment:

Procedure: surgical intervention for creation of a fistula

graft surgically placed

Active Comparator group

Description:

Randomized group to have surgically placed graft for permanent hemodialysis access

Treatment:

Device: AV graft