A pilot randomized trial of arteriovenous fistula versus arteriovenous graft in elderly patients with advanced kidney disease

老年晚期肾病患者动静脉内瘘与动静脉移植的随机试验

• 批准号: 9162029
• 负责人: Maya K Rao
• 金额: $ 12万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9162029
• 关键词: Address; Age; Aging; Arteriovenous fistula; Blood Vessels; Cardiovascular Diseases; Catheters; Clinical; Clinical Practice Guideline; Clinical Trials; Coagulation Process; Collaborations; Complication; Counseling; Coupled; Data; Dialysis patients; Dialysis procedure; Elderly; End stage renal failure; Failure; Foundations; Gait speed; Geriatrics; Goals; Guidelines; Hand; Hand Strength; Health; Hemodialysis; Incidence; Infection; Investigation; Ischemia; Kidney Diseases; Knowledge; Life Expectancy; Lower Extremity; Measurement; Measures; Medicare; Methods; Monitor; Multicenter Studies; Nephrology; Observational Study; Occupational Therapist; Occupational Therapy; Operative Surgical Procedures; Outcome Measure; Patient Self-Report; Patients; Performance; Pilot Projects; Policies; Population; Practice Guidelines; Procedures; Protocols documentation; Quality of life; Randomized; Repeat Surgery; Research; Retrospective Studies; Risk; Shoulder; Stenosis; Surgeon; Surveys; Testing; Thrombosis; Time; Training; United States National Institutes of Health; Upper Extremity; Vascular Diseases; Venous; abstracting; arm; clinical practice; disability; follow-up; functional decline; functional status; interest; mortality; multidisciplinary; older patient; preference; randomized trial; trial comparing

Abstract: Background: The elderly population is the fastest growing segment of the dialysis population. Clinical practice guidelines and Medicare pay for performance policy support arteriovenous fistulas (AVFs) over arteriovenous grafts (AVGs) as the preferred vascular access for dialysis. Older adults have higher rates of AVF non- maturation and primary AVF failure leading to the need for further procedures. Thus, the preferred choice of vascular access in the elderly is unclear. The effects of vascular access placement and endovascular procedures to achieve access functionality on a patient’s functional status are unknown. 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 those age 75 years and older than the general dialysis population. Methods: A pilot, single-center, randomized trial of 90 subjects to evaluate complication rates and functional status decline in subjects age 75 years and older referred for vascular access placement. Subjects will be randomized to AVF (n = 45) versus AVG (n = 45), placed in a vascular access monitoring protocol, and undergo measurements of 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 composite primary endpoint of a clotted 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 mean change over 6 months in gait speed, grip strength, and self-reported function as assessed by the Disabilities in Arm, Shoulder and Hand Survey. Conclusion: We have brought together experts in nephrology, vascular surgery, geriatrics, ageing research and occupational therapy to collaborate on this study. Through this collaboration, we are able to approach the question of the preferred vascular access in the elderly population with the multi-disciplinary approach it requires. Given the high incidence rates of end stage renal disease in the elderly population in the U.S., and that policy currently supports only AVF as the preferred vascular access, this study has the potential to fundamentally change clinical practice in nephrology. This pilot study will provide critical preliminary data to serve as the foundation for a NIH application evaluating the use of AVF and AVG in a large, multi-center study in the elderly population with adequate follow-up time to support investigation of the effect of access choice on access related complications, access at the start of dialysis, functional status, quality of life and mortality.

摘要： 背景：老年人口是透析人口中增长最快的部分。临床实践 指导方针和医疗保险支付绩效政策支持动静脉瘘(AVF)胜过动静脉 移植物(AVG)作为透析的首选血管通路。老年人AVF非心绞痛发生率较高 成熟期和原发动静脉动静脉瘘失败导致需要进一步的手术。因此，首选的是 老年人的血管通路尚不清楚。血管通路置入和血管内治疗的效果 在患者的功能状态上实现进入功能的程序是未知的。放置一个 透析通路以及随后实现和维持通路功能所需的程序可能 导致本已脆弱的人口的功能进一步下降，并可能降低生活质量。高 心血管疾病的负担、不同的预期寿命和不同的健康目标可能会使 血管通路的理想选择在75岁及以上的人群中不同于普通透析人群。 方法：对90名受试者进行试点、单中心、随机试验，评估并发症发生率和功能 75岁及以上接受血管通路置入术的受试者的状态下降。主题将是 随机分为AVF(n=45)和AVG(n=45)，放置在血管通路监测方案中； 在6个月内进行步速、握力和自我报告功能的测量。初级阶段 要测试的假设是，AVF放置将导致较高比例的主要访问失败，因为 由阻塞通道或不成熟通道或非功能性通道的复合主端点定义 与AVG安置相比，测量时间为6个月。此外，该研究将评估AVF是否 放置位置和更多的访问程序将导致功能状态更大的下降，因为 通过6个月来步态速度、握力和自我报告功能的平均变化来衡量 通过手臂、肩部和手部残疾调查进行评估。 结论：我们汇集了肾病学、血管外科、老年病学、老龄化研究和 职业治疗在这项研究上的合作。通过这次合作，我们能够接近 老年人群首选血管通路问题的多学科研究 需要。鉴于美国老年人口中终末期肾病的发病率很高，以及 该政策目前仅支持AVF作为首选的血管通路，本研究有可能 从根本上改变了肾脏病的临床实践。这项初步研究将提供关键的初步数据，以 作为在大型多中心研究中评估AVF和AVG使用的NIH应用程序的基础 在老年人群中有足够的随访时间来支持调查准入选择对 通路相关并发症、透析开始时通路、功能状态、生活质量和死亡率。