Hemodialysis in the Elderly (70yrs & Older)

Overview

This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.

Full Title of Study: “A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Autologous Arteriovenous Fistulas Versus Hemodialysis Access Grafts in Elderly Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2021

Detailed Description

This will be a prospective, single institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing autologous arteriovenous fistula versus hemodialysis access grafts in the elderly. The target sample size will include enrollment of 270 patients over a period of 5 years. The creation of an autologous arteriovenous fistula or placement of a hemodialysis access graft constitutes the two arms of the study.

Following the access creation the patients will be followed-up as per the standard and study protocol for a period of 2 years from the time of access creation.

The investigators will use block randomization to achieve a patient allocation ratio of 1:1, using varying blocks of sizes 4 and 6 in a random order as per a web-based/computer generated system maintained as a block randomization sequence/list concealed from the blinded clinical and trial research team until the end of trial. Patients will be randomly allocated based on this permuted sequence to either of the two intervention groups.

Masking will be performed and shall involve blinding of the patients participating in the trial. The research assistants involved with consenting, enrolling, data collection and follow-up, and the statistician analyzing the outcome measures will be blinded to the group assignment. The operating surgeon shall be blinded to the allocation process until the time of access creation following which the knowledge regarding the type of access creation by the surgeon is inevitable. All patients will be consented and their study related details including history, physical evaluations, diagnostic tests, etc., will be entered on a case report form and maintained on a web-based database. The patients will be followed-up for a period of 2 years from the time of initial access creation until the access is abandoned or rendered nonfunctional until the end of the study period.

Interventions

  • Procedure: Surgical fistula creation from patient’s anatomy
    • Patient will be randomized via computer system, to receive the fistula or graft. If fistula, surgeon creates fistula for hemodialysis access from patient’s anatomy.
  • Device: Surgical Graft implant
    • Patient will be randomized via computer system, to receive the fistula or graft. If graft, surgeon implants hemodialysis access using an FDA approved graft.

Arms, Groups and Cohorts

  • Active Comparator: Surgical fistula creation from patient’s anatomy
    • Patients randomized to surgical arteriovenous fistula will have a fistula surgically created from their anatomy to be used for hemodialysis access.
  • Active Comparator: Surgical graft implant
    • Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access.

Clinical Trial Outcome Measures

Primary Measures

  • Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients.
    • Time Frame: 12 months
    • Assess frequency of HD access use, abandonment, and patency at 12 months post-procedure. We will communicate with the patient every month from date of surgery until 12 months to complete questionnaires to determine access use and patency for their study related access creation
  • Functional cumulative patency rate at 12 months
    • Time Frame: 12 months
    • Functional refers to the availability of the access for hemofiltration. Primary patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention

Secondary Measures

  • Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to morbidity in the 2 years post fistula/graft procedure
    • Time Frame: 2 years
    • Using Disease Outcomes Quality Initiative quality of life tool
  • To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes.
    • Time Frame: 2 years
    • Analysis of hospital bills to compare the costs with both types of hemodialysis interventions
  • Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to mortality in the 2 years post fistula/graft procedure
    • Time Frame: 2 years
    • Using Disease Outcomes Quality Initiative quality of life tool
  • Using Disease Outcomes Quality Initiative quality of life tool to evaluate and compare the overall improvement in outcome with respect to patient’s quality of life in the 2 years post fistula/graft procedure
    • Time Frame: 2 years
    • Using Disease Outcomes Quality Initiative quality of life tool

Participating in This Clinical Trial

Inclusion Criteria

  • Aged ≥70 years of all ethnicities, and;
  • Have vascular anatomy amenable to arteriovenous fistula creation, and;
  • Diagnosed with End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min 1.73m2) as per the National Kidney Foundation guidelines needing vascular access for hemodialysis; or,
  • Currently undergoing hemodialysis with a failure of previous access; or,
  • Expected to undergo hemodialysis within 6 months of presentation.

Exclusion Criteria

  • Unable or refuse to abide with follow-up; or,
  • Known hypercoagulability syndrome or a bleeding disorder; or,
  • Intraoperative decision was made in favor of fistula instead of graft; or,
  • Active infections; or,
  • Evidence or suspicion of central vein stenosis but shall be included if a central vein catheter or pacemaker is implanted as long as the patient had a venogram within past 6 months.

Gender Eligibility: All

Minimum Age: 70 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • E. Peden, MD
  • Collaborator
    • The Methodist Hospital System
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: E. Peden, MD, Sponsor-Investigator/Principal Investigator – The Methodist Hospital System
  • Overall Official(s)
    • Eric Peden, MD, Principal Investigator, The Methodist Hospital System
  • Overall Contact(s)
    • Rachel Kronman-Gross, BS, CCRP, 713-441-6539, rkronman-gross@houstonmethodist.org

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