The Arteriovenous Vascular (AV) ACCESS Trial

• ClinicalTrials.gov Identifier: NCT04646226
• Recruitment Status: Recruiting
• First Posted: November 27, 2020
• Last Update Posted: March 6, 2023
• Sponsor: Wake Forest University Health Sciences
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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

Condition or disease	Intervention/treatment	Phase
End-Stage Kidney Disease; Hemodialysis Complication	Device: AV graft; Procedure: surgical intervention for creation of a fistula	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 262 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis
• Actual Study Start Date: August 18, 2022
• Estimated Primary Completion Date: June 30, 2026
• Estimated Study Completion Date: August 30, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: fistula surgically placed; Randomized group to have surgically placed fistula for permanent hemodialysis access	Procedure: 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)
Active Comparator: graft surgically placed; Randomized group to have surgically placed graft for permanent hemodialysis access	Device: 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)

Outcome Measures

Primary Outcome Measures :

1. Number of Catheter-free dialysis days [ Time Frame: Until death, collected up to 4 years ]
   Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days
2. Number of Infections [ Time Frame: Until death, collected up to 4 years ]
   Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment

Secondary Outcome Measures :

1. Vascular access-related cost per patient-year [ Time Frame: Year 2 ]
   The total cost will represent the sum of costs for adjuvant procedures (endovascular and surgical) related to fistula or graft access; central venous catheter (CVC) - related interventions; infectious complications related to fistula or graft access; infectious complications related to CVC; and hospitalizations related to fistula or graft access and/or CVC. All access-related costs will be expressed as mean cost (in U.S. dollars) per patient per year
2. Incidence rate of study fistula/graft primary maturation failure [ Time Frame: hour 72, Month 3, Month 6, and Year 4 ]
   Study fistula or graft primary maturation failure is defined as permanent failure of the fistula or graft before hemodialysis suitability, and the study fistula or graft access was abandoned. Causes of fistula or graft primary maturation failure include inadequate vasculature, thrombosis, inability to achieve successful cannulation, and other complications leading to nonfunctional fistula or graft - Abandonment of the study fistula or graft access is defined as the point at which the fistula or graft access cannot be cannulated and no further attempts will be made to rescue or revise the access
3. Time to successful fistula/graft access cannulation [ Time Frame: Until death, collected up to 4 years ]
   This is the time from the date of surgical creation of study AV access (fistula or graft) to the date of successful access cannulation. The date of successful access cannulation is defined as the date when the study fistula or graft access became the primary vascular access for hemodialysis (i.e., the fistula or graft access became the sole vascular access for hemodialysis and the CVC was removed)
4. Incidence rate of fistula/graft access hemodialysis suitability [ Time Frame: Month 6 ]
   Study AV access use (fistula or graft) with two needles for at least 8 out of 12 hemodialysis sessions occurring during the 30-day suitability ascertainment period
5. Functional patency of study fistula or graft access [ Time Frame: Until death, collected up to 4 years ]
   Total duration of successful use of the study fistula or graft access (i.e., the study fistula or graft access was the sole means of hemodialysis vascular access)
6. Rate of adjuvant endovascular and surgical procedures [ Time Frame: Until death, collected up to 4 years ]
   All endovascular and surgical procedures performed to evaluate the study fistula or graft access, or to aid or maintain study fistula or graft access functional patency will be included in this outcome. Adjuvant endovascular interventions include: percutaneous thrombectomy; percutaneous revision of anastomosis or dilation of vein/artery (e.g., angioplasty) with or without stent placement; and dilation of central venous stenosis. Adjuvant surgical interventions include: surgical thrombectomy; dilation of central venous stenosis; surgical revision of anastomosis or dilation of vein/artery (e.g., angioplasty) with or without stent placement; ligation of tributaries; superficialization of study fistula; second-stage planned procedure for brachio-basilic fistula creation; ligation of fistula or salvage by distal reconstruction and interval ligation due to distal ischemia.

Other Outcome Measures:

1. Vascular Access Score [ Time Frame: baseline and Months 6 and 12 ]
   Satisfaction with different processes of vascular access care (catheter, fistula, or graft) - vascular access questionnaire (VAQ) - satisfaction with the vascular access using the vascular access questionnaire - patient-reported questionnaire composed of 17 vascular access related questions with responses on a five-point Likert scale which are summed, to give a Vascular Access Score- Score range is 4 to 20, with lower scores indicating more satisfaction with the vascular access
2. SUPPORT Trial questionnaire [ Time Frame: baseline and Months 6, and 12 ]
   Will be based on the SUPPORT Trial questionnaire which has two items. The first question asks patients to choose their top priority, extension of life or relieving discomfort as much as possible. The second question asks patients to use the same categories to describe the focus of AV access care they received - This questionnaire will be analyzed using qualitative methods
3. Decision Regret Scale [ Time Frame: Months 6, and 12 ]
   Measuring the regret of AV access placement will be assessed using the Decision Regret Scale - The Decision Regret Scale is a 5-item Likert-type measure written to assess regret or remorse following a medical decision. Patients respond to the items after reading the prompt: "Please think about the decision you made about [chosen health care decision] after talking to your [doctor, surgeon, nurse, health professional, etc.]." High scores suggest high regret over a health care decision. Scores may be transformed to a scale of 0 (no regret) to 100 (high regret)
4. Attitude Scale [ Time Frame: Months 6, and 12 ]
   Participant's preferences between quantity and quality of life and future/present health using the Attitude Scale - An attitude scale is designed to provide a valid, or accurate, measure of an individual's social attitude - The Attitude Scale is composed of 9 items in which participants are asked to rate the strength of the statements, each representing a tradeoff between quality and quantity of life; total score range 9 to 45, with higher scores denoting that quality of life/current health is more important than quantity of life/future health
5. Grip strength [ Time Frame: Months 1, 6, and 12 ]
   Assessed with upper arm grip-strength test in each arm using a hand-held dynamometer - A dynamometer provides objective grip strength data. Males normally can generate about 46 kg of force, and females about 23 kg - A cut-off point <16 kg in women and <26 kg in men will define muscle weakness
6. Chair stand test [ Time Frame: Months 1, 6, and 12 ]
   The chair stand testing will be a timed repetition of rising from a chair and sitting down five times. The test will be scored based on the time (seconds) it takes to complete the five consecutive stand-up-sit-down workouts - longer times denotes worse outcomes. The score ranges from 0 to 4 based on pre-established time cut-offs: 4 points if ≤11.19 sec, 3 points if 11.20-13.69 sec, 2 points if 13.70-16.69 sec, 1 point if ≥16.70 sec, and 0 points if >60 sec or unable.
7. Clinical Frailty Scale [ Time Frame: Months 1, 6, and 12 ]
   Participant's level of frailty using the Clinical Frailty Scale - The Clinical Frailty Scale (CFS) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill) -The scale will be graded from 1 to 7 (1, severely frail; 2, moderately frail; 3, mildly frail; 4, apparently vulnerable; 5, well with treated comorbid disease; 6, well without active disease; 7, very fit
8. Pepper Assessment Tool for Disability (PAT-D) [ Time Frame: Months 1, 6, and 12 ]
   Self-report disability questionnaire using the Pepper Assessment Tool for Disability - The PAT-D self-administered questionnaire consists of 23 items that include a range of activities that assess mobility, activities of daily living (ADL) and instrumental activities of daily living (IADL). For each item, respondents answer whether they experience (1) unable to do, (2) a lot of difficulty, (3) some difficulty, (4) a little difficulty, (5) no difficulty. The summary score, a mean of the three domain scores that ranges from 1 to 5, is an indication of a person's overall perceived disability.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Brindusa Burciu; 336-716-8671; bburciu@wakehealth.edu

Contact: Ben Bagwell; 336-716-5777; bbagwell@wakehealth.edu

Locations

United States, Alabama

University of Alabama at Birmingham School of Medicine; Recruiting

Birmingham, Alabama, United States, 35487

Contact: Timmy Lee tclee@uabmc.edu

United States, California

UCLA; Recruiting

Los Angeles, California, United States, 90095

Contact: Karen Woo kwoo@mednet.ucla.edu

United States, Maryland

Johns Hopkins School of Medicine; Recruiting

Baltimore, Maryland, United States, 21205

Contact: Geetha Duvuru gduvura@jhmi.edu

United States, North Carolina

Atrium Wake Forest Baptist Medical Center; Recruiting

Winston-Salem, North Carolina, United States, 27157

Contact: Matthew Goldman mgoldman@wakehealth.edu

United States, Wisconsin

University of Wisconsin School of Medicine and Public Health; Recruiting

Madison, Wisconsin, United States, 53726

Contact: Ali I Gardezi AGardezi@uwhealth.org

Sponsors and Collaborators

Wake Forest University Health Sciences

National Institute on Aging (NIA)

Investigators

• Principal Investigator: Marianna Murea, MD; Wake Forest Health Sciences
• Principal Investigator: Michael Allon; University of Alabama at Birmingham

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT04646226
• Other Study ID Numbers: IRB00069593; 1R01AG071803-01 ( U.S. NIH Grant/Contract )
• First Posted: November 27, 2020
• Last Update Posted: March 6, 2023
• Last Verified: September 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Available upon investigator request

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Wake Forest University Health Sciences:

Hemodialysis; End-Stage Kidney Disease; central venous catheters; arteriovenous fistula [AVF]; arteriovenous graft [AVG]; Arteriovenous Vascular Access

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency