Comparison of AVF Versus AVG in Elderly Patients Starting Dialysis
Completed · Not applicable
Conditions studied: Chronic Kidney Disease, Endstage Renal Disease
In brief
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.
Key facts
- Study ID
- NCT02981706
- Run by
- Columbia University
- People needed
- 20
- Starts
- 2016-10-06
- Expected to finish
- 2019-02-15
- Last updated by the study team
- 2019-08-30
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 65 years or older
- Referred by nephrology provider for vascular access for hemodialysis (HD)
- Able and willing to provide informed consent
You may not qualify if…
- 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
Where it is running
- Columbia University Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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