The Arteriovenous Vascular (AV) ACCESS Trial

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04646226

Collaborator

National Institute on Aging (NIA) (NIH)

262

Enrollment

Locations

Arms

48.5

Anticipated Duration (Months)

43.7

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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	N/A

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

Anticipated 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 lifeStudy 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

Anticipated Study Start Date :

Aug 15, 2022

Anticipated Primary Completion Date :

Jun 30, 2026

Anticipated Study Completion Date :

Aug 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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)

Arm

Intervention/Treatment

Active Comparator: 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

Number of Catheter-free dialysis days [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
Number of Infections [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

Vascular access-related cost per patient-year [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
Incidence rate of study fistula/graft primary maturation failure [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
Time to successful fistula/graft access cannulation [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)
Incidence rate of fistula/graft access hemodialysis suitability [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
Functional patency of study fistula or graft access [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)
Rate of adjuvant endovascular and surgical procedures [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

Vascular Access Score [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
SUPPORT Trial questionnaire [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
Decision Regret Scale [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)
Attitude Scale [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
Grip strength [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
Chair stand test [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.
Clinical Frailty Scale [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
Pepper Assessment Tool for Disability (PAT-D) [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

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 65 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: coronary artery disease, peripheral arterial 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

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham School of Medicine	Birmingham	Alabama	United States	35487
2	UCLA	Los Angeles	California	United States	90095
3	Johns Hopkins School of Medicine	Baltimore	Maryland	United States	21205
4	Duke University Medical Center	Durham	North Carolina	United States	27710
5	Cleveland Clinic Glickman Urological and Kidney Institute	Cleveland	Ohio	United States	44125
6	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin	United States	53726