Clinical trial NCT03545113: Graft-first Versus Fistula-first in Older Patients With End-stage Kidney Disease
Official title: A Randomized Pilot Study Comparing Graft-first to Fistula-first Strategies in Older Patients With Incident End-stage Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Keywords: graft
fistula
hemodialysis
Vascular access
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-06-04
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Feasibility- Eligibility for Randomization
timeFrame: 12 months
measure: Feasibility- Consent to Randomization
timeFrame: 12 months
measure: Feasibility- AV Graft or Fistula Placement
timeFrame: Day 90
Secondary outcomes:
measure: Upper Extremity Strength
timeFrame: 3 and 6 months
measure: Patient Satisfaction With Vascular Access
timeFrame: 3 and 6 months
measure: Performance on Activities of Daily Living (ADLs)
timeFrame: Baseline and 6 months
measure: Performance on Activities of Instrumental Daily Living ADLs (IADLs)
timeFrame: Baseline, 3 and 6 months
measure: Depression
timeFrame: 3 and 6 months
measure: Health-related Quality of Life (HRQoL) - Mental Health (MCS-12) Scores
timeFrame: Baseline, Month 3, and Month 6
measure: Health-related Quality of Life (HRQoL) - Physical Health (PCS-12) Scores
timeFrame: 3 and 6 months
measure: Physical Activity Level
timeFrame: 3 and 6 months
measure: Physical Activity Level 4-meter Gait
timeFrame: Baseline, month 3 and 6
measure: Number of Subjects With No Pain at the AV Access Site
timeFrame: Baseline, 3 and 6 months
measure: Number of Subjects With Mild Pain at the AV Access Site
timeFrame: Baseline, Month 3 and Month 6
measure: Number of Subject With Moderate Pain at the AV Access Site
timeFrame: Baseline, Month 3 and Month 6
measure: Number of Subjects With Severe Pain at the AV Access Site
timeFrame: Baseline, Month 3 and Month 6
Other outcomes:
measure: AV Access Primary Failure
timeFrame: 6 months
measure: AV Access Infection
timeFrame: 12 months
measure: AV Access Successful Cannulation
timeFrame: 6 months
measure: AV Access Secondary Failure
timeFrame: 12 months
measure: AV Access Procedures - Number of Surgical Re-intervention on Index AV Access Procedures
timeFrame: 12 months
measure: AV Access Procedures - Number of Endovascular Interventions on Index AV Procedures Access
timeFrame: 12 months
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mariana Murea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.