The Arteriovenous Vascular (AV) ACCESS Trial

Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days

Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment

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

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

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)

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

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)

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.

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

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

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)

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

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

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.

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

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.