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

Mariana Murea; Ali I Gardezi; Mathew P Goldman; Caitlin W Hicks; Timmy Lee; John P Middleton; Roman Shingarev; Tushar J Vachharajani; Karen Woo; Lama M Abdelnour; Kyla M Bennett; Duvuru Geetha; Lee Kirksey; Kevin W Southerland; Carlton J Young; William M Brown; Judy Bahnson; Haiying Chen; Michael Allon

doi:10.1186/s12882-023-03086-5

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

BMC Nephrol. 2023 Feb 24;24(1):43. doi: 10.1186/s12882-023-03086-5.

Authors

Mariana Murea^{1

1}, Ali I Gardezi², Mathew P Goldman³, Caitlin W Hicks⁴, Timmy Lee^{5

6}, John P Middleton⁷, Roman Shingarev⁸, Tushar J Vachharajani⁹, Karen Woo¹⁰, Lama M Abdelnour¹¹, Kyla M Bennett¹², Duvuru Geetha¹³, Lee Kirksey¹⁴, Kevin W Southerland¹⁵, Carlton J Young¹⁶, William M Brown¹⁷, Judy Bahnson¹⁷, Haiying Chen¹⁷, Michael Allon^{18

18}

Affiliations

¹ Department of Internal Medicine, Section on Nephrology, Wake Forest School of Medicine, Winston-Salem, NC, USA. mmurea@wakehealth.edu.
² Division of Nephrology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
³ Department of Vascular and Endovascular Surgery, Wake Forest School of Medicine, Winston- Salem, NC, USA.
⁴ Department of Surgery, Division of Vascular Surgery and Endovascular Therapy, Johns Hopkins University School of Medicine, 600 N Wolfe St, Halsted 668, Baltimore, MD, USA.
⁵ Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
⁶ Division of Nephrology, Birmingham Veterans Affairs Medical Center, Birmingham, AL, USA.
⁷ Division of Nephrology, Department of Medicine, Duke University Medical Center, Durham, NC, USA.
⁸ Department of Kidney Medicine, Cleveland Clinic, Cleveland, OH, USA.
⁹ Department of Kidney Medicine, Glickman Urological & Kidney Institute, Cleveland Clinic Lerner College of Medicine, Cleveland Clinic, Cleveland, OH, USA.
¹⁰ Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
¹¹ Department of Medicine, Division of Nephrology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA.
¹² Division of Vascular Surgery, Department of Surgery, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
¹³ Division of Nephrology, Department of Medicine, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
¹⁴ Department of Vascular Surgery, Cleveland Clinic, Cleveland, OH, USA.
¹⁵ Division of Vascular & Endovascular Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA.
¹⁶ Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.
¹⁷ Department of Biostatistics and Data Science, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, NC, USA.
¹⁸ Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. mallon@uabmc.edu.

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).

Keywords: Arteriovenous access; Fistula; Graft; Hemodialysis; Older adults.

Publication types

Clinical Trial Protocol
Research Support, N.I.H., Extramural

MeSH terms

Aged
Arteriovenous Fistula*
Arteriovenous Shunt, Surgical* / methods
Humans
Kidney Failure, Chronic* / therapy
Middle Aged
Multicenter Studies as Topic
Prospective Studies
Randomized Controlled Trials as Topic
Renal Dialysis / methods
Retrospective Studies
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04646226

Grants and funding

R01 AG071803/AG/NIA NIH HHS/United States