A Pilot Randomized Trial of Arteriovenous Fistula (AVF) Versus Arteriovenous Graft (AVG) in Elderly Patients With Advanced Chronic Kidney Disease (CKD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of Patients with Primary Access Failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years or older
- •Referred by nephrology provider for vascular access for hemodialysis (HD)
- •Able and willing to provide informed consent
排除标准
- •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
研究组 & 干预措施
Arteriovenous Graft (AVG) Group
Patient will receive an arteriovenous graft (synthetic connection between artery and vein) as his/her dialysis access
干预措施: Arteriovenous Graft (AVG) (Procedure)
Arteriovenous Fistula (AVF) Group
Patient will receive an arteriovenous fistula (connection between native artery and vein) as his/her dialysis access
干预措施: Arteriovenous Fistula (AVF) (Procedure)
结局指标
主要结局
Proportion of Patients with Primary Access Failure
时间窗: 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.
次要结局
- 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)
研究者
Maya Rao
Assistant Professor of Medicine
Columbia University