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

医学 肾病科 动静脉瘘 血管通路 血液透析 随机对照试验 内科学 血液透析通路 终末期肾病 终末期肾病 肾脏疾病 外科
作者
Mariana Murea,Ali I. Gardezi,Mathew P. Goldman,Caitlin W. Hicks,Timmy Lee,John P. Middleton,Roman Shingarev,Tushar J. Vachharajani,Karen Woo,Lama Abdelnour,Kyla M. Bennett,Duvuru Geetha,Lee Kirksey,Kevin W. Southerland,Carlton J. Young,W. Mark Brown,Judy Bahnson,Haiying Chen,Michael Allon
出处
期刊:BMC Nephrology [BioMed Central]
卷期号:24 (1) 被引量:7
标识
DOI:10.1186/s12882-023-03086-5
摘要

Abstract Background Treatment of end-stage kidney disease (ESKD) with hemodialysis requires surgical creation of an arteriovenous (AV) vascular access—fistula (AVF) or graft (AVG)—to avoid (or limit) the use of a central venous catheter (CVC). AVFs have long been considered the first-line vascular access option, with AVGs as second best. Recent studies have suggested that, in older adults, AVGs may be a better strategy than AVFs. Lacking evidence from well-powered randomized clinical trials, integration of these results into clinical decision making is challenging. The main objective of the AV Access Study is to compare, between the two types of AV access, clinical outcomes that are important to patients, physicians, and policy makers. Methods This is a prospective, multicenter, randomized controlled trial in adults ≥ 60 years old receiving chronic hemodialysis via a CVC. Eligible participants must have co-existing cardiovascular disease, peripheral arterial disease, and/or diabetes mellitus; and vascular anatomy suitable for placement of either type of AV access. Participants are randomized, in a 1:1 ratio, to a strategy of AVG or AVF creation. An estimated 262 participants will be recruited across 7 healthcare systems, with average follow-up of 2 years. Questionnaires will be administered at baseline and semi-annually. The primary outcome is the rate of CVC-free days per 100 patient-days. The primary safety outcome is the cumulative incidence of vascular access (CVC or AV access)-related severe infections—defined as access infections that lead to hospitalization or death. Secondary outcomes include access-related healthcare costs and patients’ experiences with vascular access care between the two treatment groups. Discussion In the absence of studies using robust and unbiased research methodology to address vascular access care for hemodialysis patients, clinical decisions are limited to inferences from observational studies. The goal of the AV Access Study is to generate evidence to optimize vascular access care, based on objective, age-specific criteria, while incorporating goals of care and patient preference for vascular access type in clinical decision-making. Trial registration : This study is being conducted in accordance with the tenets of the Helsinki Declaration, and has been approved by the central institutional review board (IRB) of Wake Forest University Health Sciences (approval number: 00069593) and local IRB of each participating clinical center; and was registered on Nov 27, 2020, at ClinicalTrials.gov (NCT04646226).
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
sciforce完成签到,获得积分10
1秒前
李霞客完成签到,获得积分10
1秒前
迅速的婷冉完成签到,获得积分10
2秒前
6秒前
康轲发布了新的文献求助10
11秒前
ff完成签到,获得积分20
12秒前
12秒前
17秒前
18秒前
18秒前
充电宝应助wsh采纳,获得10
20秒前
niuniu发布了新的文献求助30
22秒前
八宝完成签到 ,获得积分10
23秒前
yema完成签到 ,获得积分10
23秒前
今后应助jzy采纳,获得30
23秒前
小慧儿完成签到 ,获得积分10
23秒前
24秒前
24秒前
CodeCraft应助生动的凡采纳,获得10
24秒前
科研通AI2S应助科研通管家采纳,获得10
24秒前
24秒前
爆米花应助科研通管家采纳,获得10
24秒前
24秒前
24秒前
25秒前
田様应助dyd采纳,获得10
28秒前
wsh发布了新的文献求助10
30秒前
科研通AI5应助晨曦采纳,获得30
32秒前
呜呼啦呼完成签到 ,获得积分10
33秒前
不安服饰完成签到,获得积分10
34秒前
爱学习的悦悦子完成签到 ,获得积分10
34秒前
Benjamin完成签到 ,获得积分10
35秒前
38秒前
39秒前
39秒前
NANA完成签到,获得积分10
41秒前
43秒前
dyd发布了新的文献求助10
44秒前
老陈发布了新的文献求助10
46秒前
47秒前
高分求助中
【此为提示信息,请勿应助】请按要求发布求助,避免被关 20000
Encyclopedia of Geology (2nd Edition) 2000
Maneuvering of a Damaged Navy Combatant 650
Периодизация спортивной тренировки. Общая теория и её практическое применение 310
Mixing the elements of mass customisation 300
the MD Anderson Surgical Oncology Manual, Seventh Edition 300
Nucleophilic substitution in azasydnone-modified dinitroanisoles 300
热门求助领域 (近24小时)
化学 材料科学 医学 生物 工程类 有机化学 物理 生物化学 纳米技术 计算机科学 化学工程 内科学 复合材料 物理化学 电极 遗传学 量子力学 基因 冶金 催化作用
热门帖子
关注 科研通微信公众号,转发送积分 3780127
求助须知:如何正确求助?哪些是违规求助? 3325442
关于积分的说明 10223131
捐赠科研通 3040629
什么是DOI,文献DOI怎么找? 1668938
邀请新用户注册赠送积分活动 798857
科研通“疑难数据库(出版商)”最低求助积分说明 758623