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.
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.
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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
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发表时间：
2023-02-24
期刊：
影响因子：
2.3
通讯作者：
Allon, Michael
中科院分区：
文献类型：
--
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
采用血液透析治疗终末期肾病（ESKD）需要通过手术建立动静脉（AV）血管通路-瘘（AVF）或移植物（AVG）-以避免（或限制）使用中心静脉导管（CVC）。AVF长期以来一直被认为是一线血管通路选择，AVG是第二佳选择。最近的研究表明，在老年人中，AVG可能是比AVF更好的策略。由于缺乏来自有效随机临床试验的证据，将这些结果整合到临床决策中具有挑战性。AV通路研究的主要目的是比较两种AV通路的临床结局，这对患者、医生和政策制定者都很重要。这是一项在通过CVC接受长期血液透析的≥ 60岁成人中开展的前瞻性、多中心、随机对照试验。合格的受试者必须患有并存的心血管疾病、外周动脉疾病和/或糖尿病;并且血管解剖结构适合放置任何一种类型的AV入路。受试者以1：1的比例随机接受AVG或AVF创建策略。预计将在7个医疗保健系统招募262名参与者，平均随访2年。将在基线时和每半年进行一次问卷调查。主要结局是每100患者日的无CVC天数比率。主要安全性结局是血管通路（CVC或AV通路）相关严重感染的累积发生率-定义为导致住院或死亡的通路感染。次要结局包括两个治疗组之间与血管通路相关的医疗费用和患者的血管通路护理经验。在缺乏使用稳健和无偏倚的研究方法来解决血液透析患者血管通路护理的研究的情况下，临床决策仅限于观察性研究的推论。AV入路研究的目标是根据客观的、年龄特异性标准，生成优化血管入路护理的证据，同时将护理目标和患者对血管入路类型的偏好纳入临床决策。：本研究按照赫尔辛基宣言的原则进行，并已获得维克森林大学健康科学中心机构审查委员会（IRB）（批准编号：00069593）和各参与临床中心的当地IRB的批准;并于2020年11月27日在ClinicalTrials.gov（NCT 04646226）注册。在线版本包含补充材料，可通过10.1186/s12882-023-03086-5获得。
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. 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. 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. : 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). The online version contains supplementary material available at 10.1186/s12882-023-03086-5.
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影响因子：
3.1
作者：
Leaf, DA;Macrae, HSH;Kraut, J
通讯作者：
Kraut, J
DOI：
10.1016/0266-7681(93)90212-x
发表时间：
1993-02-01
期刊：
JOURNAL OF HAND SURGERY-BRITISH AND EUROPEAN VOLUME
影响因子：
--
作者：
HARKONEN, R;PIIRTOMAA, M;ALARANTA, H
通讯作者：
ALARANTA, H
影响因子：
13.6
作者：
Brown, Robert S.;Patibandla, Bhanu K.;Goldfarb-Rumyantzev, Alexander S.
通讯作者：
Goldfarb-Rumyantzev, Alexander S.
影响因子：
2.3
作者：
Bae, Eunjin;Lee, Hajeong;Joo, Kwon Wook
通讯作者：
Joo, Kwon Wook
影响因子：
13.2
作者：
Lee, Timmy;Qian, Joyce;Allon, Michael
通讯作者：
Allon, Michael