Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 65 - Any |
| Updated: | 7/21/2018 |
| Start Date: | October 2016 |
| End Date: | October 2019 |
| Contact: | Maya Rao, MD |
| Email: | mr2971@cumc.columbia.edu |
| Phone: | 212-305-5020 |
A Pilot Randomized Trial of Arteriovenous Fistula (AVF) Versus Arteriovenous Graft (AVG) in Elderly Patients With Advanced Chronic Kidney Disease (CKD)
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.
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.
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.
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.
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
We found this trial at
1
site
630 W 168th St
New York, New York
New York, New York
212-305-2862
Phone: 212-305-5020
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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