A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults with End-Stage Kidney Disease on Hemodialysis: The AV ACCESS Trial

血液透析终末期肾病老年人中瘘管与移植动静脉血管通路的随机试验：AV ACCESS 试验

• 批准号: 10684934
• 负责人: MICHAEL ALLON
• 金额: $ 119.14万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10684934
• 关键词: Address; Adjuvant; Adult; Age; Age Years; Aging; American; Anatomy; Arteriovenous fistula; Assessment tool; Attention; Biological Factors; Blood Vessels; Capsicum; Caring; Catheters; Cessation of life; Characteristics; Chronic; Client satisfaction; Clinical; Clinical Trials; Complex; Coronary Arteriosclerosis; Data; Dependence; Diabetes Mellitus; Diagnosis; Dialysis procedure; Disadvantaged; Disease; Economics; Effectiveness of Interventions; Elderly; End stage renal failure; Enrollment; Exhibits; Failure; Fistula; Goals; Hand Strength; Health; Health Care Costs; Health Services Accessibility; Hemodialysis; High Prevalence; Hospitalization; Incidence; Infection; Intervention; Link; Longevity; Measurement; Measures; Medical center; Observational Study; Operative Surgical Procedures; Outcome; Participant; Patient Outcomes Assessments; Patient Preferences; Patient-Focused Outcomes; Patients; Peripheral arterial disease; Physical Function; Population; Procedures; Randomized; Reporting; Research; Research Methodology; Risk; Role; Safety; Site; Testing; Time; Vascular Graft; Venous; arteriovenous graft; care preference; clinical practice; comorbidity; comparative; cost; disability; eligible participant; evidence base; feasibility testing; follow-up; frailty; health assessment; human old age (65+); infection rate; infection risk; novel; older patient; pilot trial; primary outcome; public health priorities; randomized trial; randomized, clinical trials; research study; safety outcomes; satisfaction

ABSTRACT End-stage kidney disease is a disease of aging, exacerbated by multiple coexisting health conditions. Nearly 50% of patients initiating chronic hemodialysis for treatment of end-stage kidney disease are 65 years or older. Patients who use central venous catheters for hemodialysis access typically undergo surgical placement of an arteriovenous access—either a fistula or a graft—to reduce the risks of infection, vascular complications and death associated with catheter use. Arteriovenous fistulas have long been considered first-line vascular access option, with grafts as second best. However, several recent studies suggest that grafts may be a better strategy than fistulas for hemodialysis access in older adults. Without evidence from well-powered randomized clinical trials, these studies cannot be integrated into practice. We conducted the first pilot trial (N=46) that revealed the feasibility of enrolling and randomizing older adults to surgical fistula or graft placement, with 89% (20 of 22) of those assigned to fistula and 79% (19 of 24) of those assigned to graft placement undergoing the assigned intervention. Building on this successful pilot, we propose a pragmatic multicenter randomized clinical trial in 262 adults, 65 years of age and older, receiving hemodialysis via catheters. Unbiased, comparative characterization of clinical outcomes and patient views between alternative access strategies will advance the field, for the first time, to evidence-based vascular access care. Our long-term goals are to optimize clinical decisions based on objective, age-specific data while incorporating goals of care and patient preference for vascular access type. The objective of this proposal is to delineate vascular access effects on disease-specific and patient-reported outcomes, using a randomized intervention, at 6 national sites, of surgical fistula versus graft placement in older adults who have end-stage kidney disease and coexisting coronary artery disease, peripheral arterial disease, and/or diabetes mellitus. The overarching hypothesis is that graft placement strategy will yield more dialysis catheter-free days, lower cost, and better patient satisfaction. Our Specific Aims will determine the effects of fistula versus graft vascular access strategy on rates of catheter-free dialysis days and access-related infections and death (Primary Aim), costs associated with vascular access care (Secondary Aim), and patient-reported satisfaction with access-related outcomes (Tertiary Aim). We will also investigate the relationship between preoperative objective and subjective measures of physical function and failure of fistula or graft maturation (Exploratory Aim). Results from this trial could transform the clinical practice by providing high-quality evidence to guide common clinical decisions on dialysis vascular access in older adults—a growing population whose care is complex and costly.

抽象的 终末期肾病是一种衰老疾病，多种共存的健康状况会加剧这种疾病。 50% 开始慢性血液透析治疗终末期肾病的患者年龄为 65 岁或以上。 使用中心静脉导管进行血液透析的患者通常会接受手术放置 动静脉通路（无论是瘘管还是移植物），以减少感染、血管并发症和 长期以来，动静脉瘘一直被认为是一线血管通路。 然而，最近的几项研究表明，移植可能是更好的选择。 在没有强有力的随机证据的情况下，这种策略比瘘管更适合老年人的血液透析。 临床试验，这些研究无法融入实践，我们进行了第一个试点试验（N=46）。 揭示了招募和随机分组老年人进行手术瘘管或移植物放置的可行性，89% 分配给瘘管的患者中（22 名中的 20 名）和分配给移植物置入组中的 79%（24 名中的 19 名）接受了 在此成功试点的基础上，我们提出了一项务实的多中心随机临床试验。 在 262 名 65 岁及以上的成年人中进行的试验，通过导管接受血液透析，无偏见、比较。 替代访问策略之间临床结果和患者观点的表征将推动 首次进入循证血管通路护理领域，我们的长期目标是优化临床。 基于客观、特定年龄数据的决策，同时结合护理目标和患者偏好 该提案的目的是描述血管通路对特定疾病的影响。 以及患者报告的结果，使用随机干预措施，在 6 个国家地点进行手术瘘与 对患有终末期肾病并合并冠状动脉疾病的老年人进行移植物植入， 外周动脉疾病和/或糖尿病总体假设是移植物放置。 该策略将带来更多的无透析导管天数、更低的成本和更好的患者满意度。 目的将确定瘘管与移植血管通路策略对无导管透析率的影响 天数和通路相关感染和死亡（主要目标），与血管通路护理相关的费用 （次要目标），以及患者报告的对访问相关结果的满意度（第三级目标）。 研究术前客观和主观身体功能测量之间的关系 瘘管或移植物成熟失败（探索性目标）。该试验的结果可能会改变临床实践。 通过提供高质量的证据来指导老年人透析血管通路的常见临床决策 成年人——不断增长的人口，其护理复杂且昂贵。

项目成果

Integrated Collection of Patient-Reported Outcomes and Experiences in Children with Kidney and Hematological Diseases: A Pilot Study.

• DOI: 10.3390/children10071245
• 发表时间: 2023-07-19
• 期刊: CHILDREN-BASEL
• 影响因子: 2.4
• 作者: Azukaitis, Karolis;Puronaite, Roma;Vaitkeviciene, Goda Elizabeta;Trinkunas, Justas;Jankauskiene, Augustina;Jankauskiene, Danguole
• 通讯作者: Jankauskiene, Danguole

Development of Wireless Sensor Network for Environment Monitoring and Its Implementation Using SSAIL Technology.

• DOI: 10.3390/s22145343
• 发表时间: 2022-07-18
• 期刊: Sensors (Basel, Switzerland)

Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial.

血液透析终末期肾病老年人的瘘管与移植动静脉血管通路的随机对照试验的研究方案：AV 通路试验。

• DOI: 10.1186/s12882-023-03086-5
• 发表时间: 2023-02-24
• 期刊: BMC NEPHROLOGY
• 影响因子: 2.3
• 作者: Murea, Mariana;Gardezi, Ali I.;Goldman, Mathew P.;Hicks, Caitlin W.;Lee, Timmy;Middleton, John P.;Shingarev, Roman;Vachharajani, Tushar J.;Woo, Karen;Abdelnour, Lama M.;Bennett, Kyla M.;Geetha, Duvuru;Kirksey, Lee;Southerland, Kevin W.;Young, Carlton J.;Brown, William M.;Bahnson, Judy;Chen, Haiying;Allon, Michael
• 通讯作者: Allon, Michael

Comparative Analysis of Mesophilic YqfB-Type Amidohydrolases.

• DOI: 10.3390/biom12101492
• 发表时间: 2022-10-16
• 期刊: Biomolecules
• 影响因子: 5.5

A Single-Center Experience with Forearm Arteriovenous Loop Grafts for Hemodialysis.

用于血液透析的前臂动静脉环移植物的单中心经验。

• DOI: 10.1016/j.avsg.2022.06.003
• 发表时间: 2022
• 期刊: Annals of vascular surgery
• 影响因子: 1.5
• 作者: Brastauskas,IanM;Patel,Nimesh;German,Zachary;Davis,RossP;Stafford,JeanetteM;Edwards,Matthew;Murea,Mariana;Goldman,MatthewP
• 通讯作者: Goldman,MatthewP