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

NCT03545113 | Completed Results

• 2 other identifiers: IRB00050577R03AG060178-02
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Diseases

Keywords

graft; fistula; hemodialysis; Vascular access

Outcome Measures

Primary Outcomes (3)

• Feasibility- Eligibility for Randomization

  Proportion of screened participants deemed eligible for randomization.

  12 months

• Feasibility- Consent to Randomization

  Proportion of eligible participants who consent to randomization.

  12 months

• Feasibility- AV Graft or Fistula Placement

  Proportion of participants who undergo AV graft or fistula placement within 90 days of randomization.

  Day 90

Secondary Outcomes (13)

• Upper Extremity Strength

  3 and 6 months

• Patient Satisfaction With Vascular Access

  3 and 6 months

• Performance on Activities of Daily Living (ADLs)

  Baseline and 6 months

• Performance on Activities of Instrumental Daily Living ADLs (IADLs)

  Baseline, 3 and 6 months

• Depression

  3 and 6 months

Other Outcomes (6)

• AV Access Primary Failure

  6 months

• AV Access Infection

  12 months

• AV Access Successful Cannulation

  6 months

Study Arms (2)

Upper extremity arteriovenous graft (AVG) - first

EXPERIMENTAL

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

Procedure: Upper arm arteriovenous graft surgery

Upper extremity arteriovenous fistula (AVF) - first

ACTIVE COMPARATOR

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

Procedure: Upper arm arteriovenous fistula surgery

Interventions

Upper arm arteriovenous graft surgery PROCEDURE

Creation of arteriovenous graft vascular access for hemodialysis

Upper extremity arteriovenous graft (AVG) - first

Upper arm arteriovenous fistula surgery PROCEDURE

Creation of arteriovenous fistula vascular access for hemodialysis

Upper extremity arteriovenous fistula (AVF) - first

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (10)

• 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.

  PMID: 27516143 BACKGROUND

• 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.

  PMID: 26372193 BACKGROUND

• 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.

  PMID: 16988062 BACKGROUND

• 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.

  PMID: 18235150 BACKGROUND

• 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.

  PMID: 26254301 BACKGROUND

• 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.

  PMID: 16813989 BACKGROUND

• 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.

  PMID: 23813216 BACKGROUND

• 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.

  PMID: 19670174 BACKGROUND

• 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.

  PMID: 33851120 DERIVED

• 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.

  PMID: 32551134 DERIVED

MeSH Terms

Conditions

Kidney Diseases; Fistula

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mariana Murea, MD
• Organization: Wake Forest University Health Sciences

mmurea@wakehealth.edu

336-716-5777

Study Officials

• Mariana Murea, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: June 4, 2018
• Study Start: September 4, 2018
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: November 21, 2022
• Results First Posted: November 21, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following the first article publication that stems from this pilot trial.
• Access Criteria: Researchers who provide a methodologically sound proposal and whose proposed use of data has been approved by an independent review party identified for this purpose.

Locations

US (1)