A Pilot Randomized Trial of Arteriovenous Fistula (AVF) Versus Arteriovenous Graft (AVG) in Elderly Patients With Advanced Chronic Kidney Disease (CKD)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Kidney Disease
- Sponsor
- Columbia University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Proportion of Patients with Primary Access Failure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 65 years and older referred for vascular access placement. Subjects will be randomized to arteriovenous fistula (AVF) (n = 45) versus arteriovenous graft (AVG) (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of functional status including gait speed, grip strength, and self-reported function over 6 months. The primary hypothesis to be tested is that AVF placement will result in a higher proportion of primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months compared to AVG placement. In addition, the study will evaluate whether AVF placement and a greater number of access procedures will result in a greater decline in functional status as measured by the average change over 6 months in gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm, Shoulder and Hand Survey.
Detailed Description
The elderly population is the fastest growing segment of the dialysis population. A vascular access is required to perform dialysis and current guidelines support arteriovenous fistulas (AVFs) over arteriovenous grafts (AVGs) as the preferred vascular access for dialysis. However, the preferred choice of vascular access in the elderly is unclear. Older adults have higher rates of complications from AVF placement compared to AVG placement. Placement of a dialysis access and the procedures subsequently required to achieve and maintain access functionality could result in further declines of function in this already frail population and potentially reduce quality of life. High burdens of cardiovascular disease, heterogeneous life expectancy and variable health goals may make the ideal choice of vascular access different in the elderly population than the general dialysis population.
Investigators
Maya Rao
Assistant Professor of Medicine
Columbia University
Eligibility Criteria
Inclusion Criteria
- •Age 65 years or older
- •Referred by nephrology provider for vascular access for hemodialysis (HD)
- •Able and willing to provide informed consent
Exclusion Criteria
- •Patient is not a candidate for an AVF per surgeon
- •Congestive heart failure (CHF) as defined by ejection fraction (EF) \< 20%, history of heart transplant, history of ventricular assist device
- •Known central venous stenosis
- •Metastatic cancer or active cancer receiving chemotherapy
- •Multiple Myeloma
- •Vein mapping with arterial diameter ≤ 2mm and vein diameter ≤ 2.5mm or presence of stenosis or thrombosis in the draining vein
- •arterial flow velocity of ≤ 40ml/min
Outcomes
Primary Outcomes
Proportion of Patients with Primary Access Failure
Time Frame: Up to 6 months after procedure
Primary access failure as defined by a binary composite primary endpoint of an unsalvageable access or an immature access or a non-functional access measured at 6 months. An access determined to be unsalvageable by the vascular surgeon and requiring a new access placement will meet the primary endpoint. For subjects on HD at 6 months, self-report of successful use of the vascular access three times will be considered functional and will not meet the primary endpoint. For all subjects not on HD at 6 months, ultrasound will be performed and interpreted by the vascular surgeon, and a mature, functioning access will be defined as meeting the following criteria:1) 600ml/min blood flow, 2) 6mm diameter dilation of the access, and 3) 6mm or less depth from the skin to the access. Any vascular access that does not fulfill all three criteria will meet the primary endpoint.
Secondary Outcomes
- Mean Number of Procedures Between the Two Groups(Up to 6 months after the procedure)
- Time to Event(Up to 6 months after the procedure)
- Change in Gait Speed(Baseline, 3 months, 6 months)
- Change in Grip Strength(Baseline, 3 months, 6 months)
- Change in Disabilities of the Arm, Shoulder and Hand (DASH) Score(Baseline, 3 months, 6 months)
- Change in Cognitive Screen(Baseline and 6 months)