Clinical trial NCT04646226: The Arteriovenous Vascular (AV) ACCESS Trial
Official title: A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End-Stage Kidney Disease
Hemodialysis Complication
Keywords: Hemodialysis
End-Stage Kidney Disease
central venous catheters
arteriovenous fistula [AVF]
arteriovenous graft [AVG]
Arteriovenous Vascular Access
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-11-27
Enrollment: 103
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study will determine if placement of a graft access will be more effective at having access switched from catheter to using the graft; have fewer interventions on the graft access; have better arm function; have better self-sufficiency with daily activities; and better quality of life compared to those who receive a fistula - identify strategies that decrease dialysis access failure and improve quality of life
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Number of Catheter-free dialysis days
timeFrame: Until death, collected up to 4 years
measure: Number of Infections
timeFrame: Until death, collected up to 4 years
Secondary outcomes:
measure: Vascular access-related cost per patient-year
timeFrame: Year 2
measure: Incidence rate of study fistula/graft primary maturation failure
timeFrame: hour 72, Month 3, Month 6, and Year 4
measure: Time to successful fistula/graft access cannulation
timeFrame: Until death, collected up to 4 years
measure: Incidence rate of fistula/graft access hemodialysis suitability
timeFrame: Month 6
measure: Functional patency of study fistula or graft access
timeFrame: Until death, collected up to 4 years
measure: Rate of adjuvant endovascular and surgical procedures
timeFrame: Until death, collected up to 4 years
Other outcomes:
measure: Vascular Access Score
timeFrame: baseline and Months 6 and 12
measure: SUPPORT Trial questionnaire
timeFrame: baseline and Months 6, and 12
measure: Decision Regret Scale
timeFrame: Months 6, and 12
measure: Attitude Scale
timeFrame: Months 6, and 12
measure: Grip strength
timeFrame: Months 1, 6, and 12
measure: Chair stand test
timeFrame: Months 1, 6, and 12
measure: Clinical Frailty Scale
timeFrame: Months 1, 6, and 12
measure: Pepper Assessment Tool for Disability (PAT-D)
timeFrame: Months 1, 6, and 12
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Medicine
state: Alabama
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
city: Winston-Salem
country: United States
facility: Atrium Wake Forest Baptist Medical Center
state: North Carolina
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
city: Knoxville
country: United States
facility: University of Tennessee Medical Center at Knoxville
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: Wake Forest Health Sciences
name: Mariana Murea, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wake Forest University Health Sciences
name: Matthew P Goldman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Michael Allon, MD
role: PRINCIPAL_INVESTIGATOR
References: