A randomized pilot study comparing graft-first to fistula-first strategies in older patients with incident end-stage kidney disease

一项随机试点研究，比较患有终末期肾病的老年患者的移植优先与瘘优先策略

• 批准号: 9589949
• 负责人: Mariana Murea
• 金额: $ 11.63万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-01 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9589949
• 关键词: Activities of Daily Living; Adult; Age; Age-Years; Aging; American; Arteriovenous fistula; Biological; Biology; Blood Vessels; Cannulations; Catheters; Chronic Kidney Failure; Client satisfaction; Clinical Research; Clinical Trials; Cohort Studies; Consent; Data; Development; Dialysis procedure; Effectiveness; Elderly; End stage renal failure; Enrollment; Environment; Exhibits; Failure; Fistula; Gait speed; Gerontology; Goals; Guidelines; Hand Strength; Health; Hemodialysis; Intervention; Kidney Diseases; Life; Limb structure; Measurement; Mediating; Mediator of activation protein; Mentors; Methods; Multicenter Studies; Multicenter Trials; Muscle Weakness; Nephrology; Operative Surgical Procedures; Outcome; Outpatients; Participant; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Performance; Physical Function; Physical Performance; Pilot Projects; Procedures; Prosthesis; Quality of life; Randomized; Reporting; Research; Role; Sample Size; Savings; Secondary to; Testing; Time; Training; Translating; United States; Universities; Upper Extremity; Venous; Woman; adverse outcome; age related; arm; base; design; eligible participant; experience; forest; functional disability; functional outcomes; functional status; graft function; health related quality of life; improved; improved outcome; instrumental activity of daily living; interest; medical schools; men; muscle strength; negative affect; older patient; patient oriented; patient population; pilot trial; primary outcome; prospective; sarcopenia; satisfaction; secondary outcome; success

Project Summary/Abstract National guidelines direct nephrologists to refer patients with advanced kidney disease for placement of arteriovenous (AV) fistulas as the vascular access of choice for hemodialysis, instead of AV grafts. These guidelines were based on retrospective and observational analyses done nearly two decades ago among patients with a mean age of 59.4 years. Currently, adults 70 years of age and older comprise nearly 30% of patients with end-stage kidney disease compared to less than 15% two decades ago. Importantly, AV access placement may adversely impact upper extremity strength and function, and AV fistulas may cause greater deficits in overall physical function due to lengthier time to develop compared with AV grafts; grafts have better patency rates and can be used faster. Changes in physical abilities (i.e., precipitous decline in physical performance and self-sufficiency) are prevalent in older patients commencing hemodialysis, making the lack of data on the functional impact of initial AV access strategy (fistulas or grafts) even more critical. This GEMSSTAR proposal is focused on older patients with incident end-stage kidney disease with no prior vascular access surgery. We will randomly allocate patients undergoing hemodialysis via a tunneled catheter to either graft-first (intervention) or fistula-first (comparator) placement. Patient-centered functional outcomes (upper extremity strength, gait speed, independence and quality of life) and vascular access outcomes (AV access primary patency rate) will be compared. Our scientific premise: graft-first placement will yield higher rates of functional access, fewer following procedures to aid access development, and faster transition from catheter to AV access use; these will translate into higher patient satisfaction in the graft-first group. Our first hypothesis is that AV access placement will have adverse consequences on upper extremity function, mediated by the degree of preoperative muscle strength. We anticipate that the fistula-first strategy will have a greater negative impact on upper extremity physical function than the graft-first strategy. Our second hypothesis is that the success rate of AV access approach (i.e., primary AV access patency) will correlate with patient-reported outcomes for quality of life. The results of this study will provide critically needed data on the relationship between initial AV access approach and outcomes important to health and quality of life in older patients including the role of muscle strength in vascular access outcomes. Data from this pilot study will guide the design, conduct, and sample size for a subsequent multicenter study comparing AV fistulas to grafts in older adults with advanced chronic kidney disease, with the overarching objective of identifying strategies that decrease AV access failure rates and improve patients' quality of life. The applicant seeks to augment her expertise in clinical research with gerontology and geriatric specific training and expert mentoring to become a leader in geriatric nephrology research and improve outcomes among the growing numbers of older Americans with kidney disease. 1

项目总结/摘要 国家指南指导肾脏病学家将晚期肾病患者转诊为 动静脉（AV）瘘作为血液透析的血管通路选择，而不是AV移植物。这些 指南是基于近20年前对这些人进行的回顾性和观察性分析。 患者平均年龄为59.4岁。目前，70岁及以上的成年人占全国人口的近30%。 与20年前的不到15%相比，晚期肾病患者的比例增加了。重要的是，AV接入 放置可能会对上肢力量和功能产生不利影响，AV瘘可能会导致更大的 与AV移植物相比，由于发育时间更短，整体身体功能缺陷;移植物具有更好的 通畅率和可以更快地使用。身体能力的变化（即，体力急剧下降 性能和自给自足）在开始血液透析的老年患者中普遍存在， 关于初始AV入路策略（瘘管或移植物）的功能影响的数据甚至更为关键。这 GEMSSTAR提案的重点是既往无终末期肾病病史的老年患者 血管通路手术我们将随机分配通过隧道导管进行血液透析的患者 移植物优先（介入）或瘘管优先（对照器械）置入。以患者为中心的功能结局 （上肢力量、步态速度、独立性和生活质量）和血管通路结局（AV 入路一期通畅率）进行比较。我们的科学前提是：移植物优先放置会产生更高的产量 功能访问率，更少的后续程序，以帮助访问开发，并更快地从 导管到AV通路的使用;这些将转化为移植物优先组中更高的患者满意度。我们的第一 假设AV通路放置将对上肢功能产生不利影响， 由术前肌肉力量的程度介导。我们预计，瘘管优先战略将有一个 对上肢生理功能的负面影响大于移植物优先策略。我们的第二 假设AV进入方法的成功率（即，主AV通路通畅性）将与 患者报告的生活质量结果。这项研究的结果将提供急需的数据， 初始AV接入方法与对健康和生活质量重要的结果之间的关系， 老年患者，包括肌肉力量在血管通路结局中的作用。该试点研究的数据将 为随后比较动静脉瘘与移植物的多中心研究的设计、实施和样本量提供指导 在患有晚期慢性肾病的老年人中，总体目标是确定策略 降低AV接入失败率并改善患者的生活质量。申请人试图增加她的 在临床研究与老年学和老年人的具体培训和专家指导的专业知识，成为一个 老年肾病学研究的领导者，并改善越来越多的美国老年人的治疗结果 患有肾病 1