Clinical trial NCT02981706: Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
Official title: A Pilot Randomized Trial of Arteriovenous Fistula (AVF) Versus Arteriovenous Graft (AVG) in Elderly Patients With Advanced Chronic Kidney Disease (CKD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Endstage Renal Disease
Keywords: Arteriovenous Fistula (AVF)
Arteriovenous Graft (AVG)
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2016-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of Patients with Primary Access Failure
timeFrame: Up to 6 months after procedure
Secondary outcomes:
measure: Mean Number of Procedures Between the Two Groups
timeFrame: Up to 6 months after the procedure
measure: Time to Event
timeFrame: Up to 6 months after the procedure
measure: Change in Gait Speed
timeFrame: Baseline, 3 months, 6 months
measure: Change in Grip Strength
timeFrame: Baseline, 3 months, 6 months
measure: Change in Disabilities of the Arm, Shoulder and Hand (DASH) Score
timeFrame: Baseline, 3 months, 6 months
measure: Change in Cognitive Screen
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Maya Rao, MD
role: PRINCIPAL_INVESTIGATOR
References: