Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease

NCT ID: NCT03545113

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-04
• Study Completion Date: 2021-02-22

Brief Summary

Many older adults require hemodialysis for advanced chronic kidney disease, but it is not clear which permanent vascular access method (fistula or graft) is best with respect to access effectiveness and patient satisfaction. In this pilot study, the study team will test the hypothesis that older adults undergoing graft access placement will more effectively transition from catheter-based to arteriovenous access-based hemodialysis; have fewer following vascular access procedures; have better upper extremity function; have better self-sufficiency with daily activities; and better health-related quality of life compared to those who undergo arteriovenous fistula access placement. The study will establish feasibility of randomizing older adults to the two types of arteriovenous access surgeries; evaluate relationships between measurements of pre-operative physical function and vascular access development; compare vascular access outcomes between the two groups; and gather longitudinal assessments of upper extremity muscle strength, performance of activities of daily living, and patients' reports of satisfaction with their vascular access and quality of life.

Detailed Description

Each year, more than 600,000 people in the United States receive life-saving hemodialysis (HD) treatments for end-stage kidney disease (ESKD), a third of whom are older adults.Timely placement of an arteriovenous (AV) vascular access (native AV fistula [AVF] or prosthetic AV graft [AVG]) is necessary to avoid (or limit) the use of tunneled central venous catheters (TCVC) for HD. 'Fistula First Catheter Last' national guidelines require placement of AVF as the AV access of first choice in all patients to achieve better patient survival. However, the benefits of AVF over AVG are least certain in older adults, as age-related biological changes independently modulate patient outcomes. Nationally representative cohort studies of older adults with incident ESKD have shown similar patient survival between those whose first AV access placed or used was a fistula or a graft.Compared with grafts, fistulas fail more often and necessitate longer times and more subsequent procedures to aid development, exposing older patients to time-consuming procedures that may negatively affect upper extremity strength and erode their quality of life. The contribution of pre-operative physical function to AV access outcomes and the impact of AV access placement on upper extremity strength and self-sufficiency have not been evaluated. This pilot trial will involve older adults with pre-dialysis advanced chronic kidney disease (CKD) or incident ESKD using a TCVC for HD who had no prior AV access surgery and have upper extremity vasculature suitable for either fistula or graft placement. Participants will be randomized to receive an upper extremity AVF-first or AVG-first access for HD. The primary objective of this pilot trial is to prospectively evaluate patient and vascular access outcomes in a randomized intervention and in a patient population in whom fistula-first guidelines have been applied despite the lack of proven benefit and at the detriment of more access failures and procedures.

Conditions

Kidney Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Upper extremity arteriovenous graft (AVG) - first

Participants randomized to receive an AVG will undergo surgery to have an AVG placed.

Group Type: EXPERIMENTAL

Upper arm arteriovenous graft surgery

Intervention Type: PROCEDURE

Creation of arteriovenous graft vascular access for hemodialysis

Upper extremity arteriovenous fistula (AVF) - first

Participants randomized to receive an AVF will undergo surgery to have an AVF created.

Group Type: ACTIVE_COMPARATOR

Upper arm arteriovenous fistula surgery

Intervention Type: PROCEDURE

Creation of arteriovenous fistula vascular access for hemodialysis

Interventions

Upper arm arteriovenous graft surgery

Creation of arteriovenous graft vascular access for hemodialysis

Intervention Type: PROCEDURE

Upper arm arteriovenous fistula surgery

Creation of arteriovenous fistula vascular access for hemodialysis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 65 years
• End-stage kidney disease (ESKD) on chronic hemodialysis (HD)
• Tunneled central venous catheter (TCVC) is the sole vascular access used for HD
• Advanced chronic kidney disease (CKD) expected to require HD initiation within 90 days of screening and deemed medically necessary by the treating nephrologist to proceed with arteriovenous (AV) access placement in preparation for HD initiation
• Did not undergo AV access placement in the past
• Medically eligible to receive AV fistula (AVF) or AV graft (AVG) placement as deemed by the treating nephrologist
• Surgically eligible to receive either an AVF or an AVG as deemed by the vascular surgeon
• HD is the intended long-term modality of treatment for ESKD
• Planning to remain within Wake Forest provided health care for at least 12 months

Exclusion Criteria

• Presence of an AVF or AVG
• Previous attempt(s) for AV vascular access placement
• Native vasculature not suitable for placement of AV access
• Imminent transplant planned (within 6 months)
• Anticipated life expectancy <9 months

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariana Murea, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Countries

United States

References

Murea M, Burkart J. Finding the right hemodialysis vascular access in the elderly: a patient-centered approach. J Vasc Access. 2016 Sep 21;17(5):386-391. doi: 10.5301/jva.5000590. Epub 2016 Aug 1.

Reference Type: BACKGROUND

PMID: 27516143 (View on PubMed)

Yuo TH, Chaer RA, Dillavou ED, Leers SA, Makaroun MS. Patients started on hemodialysis with tunneled dialysis catheter have similar survival after arteriovenous fistula and arteriovenous graft creation. J Vasc Surg. 2015 Dec;62(6):1590-7.e2. doi: 10.1016/j.jvs.2015.07.076. Epub 2015 Sep 12.

Reference Type: BACKGROUND

PMID: 26372193 (View on PubMed)

Lok CE, Allon M, Moist L, Oliver MJ, Shah H, Zimmerman D. Risk equation determining unsuccessful cannulation events and failure to maturation in arteriovenous fistulas (REDUCE FTM I). J Am Soc Nephrol. 2006 Nov;17(11):3204-12. doi: 10.1681/ASN.2006030190. Epub 2006 Sep 20.

Reference Type: BACKGROUND

PMID: 16988062 (View on PubMed)

Peterson WJ, Barker J, Allon M. Disparities in fistula maturation persist despite preoperative vascular mapping. Clin J Am Soc Nephrol. 2008 Mar;3(2):437-41. doi: 10.2215/CJN.03480807. Epub 2008 Jan 30.

Reference Type: BACKGROUND

PMID: 18235150 (View on PubMed)

Woo K, Goldman DP, Romley JA. Early Failure of Dialysis Access among the Elderly in the Era of Fistula First. Clin J Am Soc Nephrol. 2015 Oct 7;10(10):1791-8. doi: 10.2215/CJN.09040914. Epub 2015 Aug 7.

Reference Type: BACKGROUND

PMID: 26254301 (View on PubMed)

Vascular Access 2006 Work Group. Clinical practice guidelines for vascular access. Am J Kidney Dis. 2006 Jul;48 Suppl 1:S176-247. doi: 10.1053/j.ajkd.2006.04.029. No abstract available.

Reference Type: BACKGROUND

PMID: 16813989 (View on PubMed)

DeSilva RN, Patibandla BK, Vin Y, Narra A, Chawla V, Brown RS, Goldfarb-Rumyantzev AS. Fistula first is not always the best strategy for the elderly. J Am Soc Nephrol. 2013 Jul;24(8):1297-304. doi: 10.1681/ASN.2012060632. Epub 2013 Jun 27.

Reference Type: BACKGROUND

PMID: 23813216 (View on PubMed)

Richardson AI 2nd, Leake A, Schmieder GC, Biuckians A, Stokes GK, Panneton JM, Glickman MH. Should fistulas really be first in the elderly patient? J Vasc Access. 2009 Jul-Sep;10(3):199-202. doi: 10.1177/112972980901000311.

Reference Type: BACKGROUND

PMID: 19670174 (View on PubMed)

Robinson T, Geary RL, Davis RP, Hurie JB, Williams TK, Velazquez-Ramirez G, Moossavi S, Chen H, Murea M. Arteriovenous Fistula Versus Graft Access Strategy in Older Adults Receiving Hemodialysis: A Pilot Randomized Trial. Kidney Med. 2021 Feb 10;3(2):248-256.e1. doi: 10.1016/j.xkme.2020.11.016. eCollection 2021 Mar-Apr.

Reference Type: DERIVED

PMID: 33851120 (View on PubMed)

Murea M, Geary RL, Houston DK, Edwards MS, Robinson TW, Davis RP, Hurie JB, Williams TK, Velazquez-Ramirez G, Bagwell B, Tuttle AB, Moossavi S, Rocco MV, Freedman BI, Williamson JD, Chen H, Divers J. A randomized pilot study to evaluate graft versus fistula vascular access strategy in older patients with advanced kidney disease: results of a feasibility study. Pilot Feasibility Stud. 2020 Jun 17;6:86. doi: 10.1186/s40814-020-00619-9. eCollection 2020.

Reference Type: DERIVED

PMID: 32551134 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R03AG060178-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00050577

Identifier Type: -

Identifier Source: org_study_id