Hemodialysis in the Elderly (70yrs & Older) (ELDERLY)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease; Kidney Failure; Kidney Disease
• Intervention / Treatment: Procedure: Surgical fistula creation from patient's anatomy; Device: Surgical Graft implant

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.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bright Benfor, MD; Phone Number: 713-441-0147; Email: bbenfor@houstonmethodist.org
• Study Contact Backup: Name: Bevin A Lopez, MS,CEP,CCRP; Phone Number: 346-320-7421; Email: balopez@houstonmethodist.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Houston Methodist Hospital
      • Sub-Investigator: Carlos Bechara, MD
      • Sub-Investigator: Linda Le, MD
      • Sub-Investigator: Thomas Loh, MD
      • Principal Investigator: Eric Peden, MD
      • Contact: Bright Benfor, MD; Phone Number: 713-441-0147; Email: bbenfor@houstonmethodist.org
      • Contact: Bevin A Lopez, MS,CEP,CCRP; Phone Number: 346-320-7421; Email: balopez@houstonmethodist.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Fistula
Active Comparator: Surgical graft implant; Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access.	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.; Other Names: Fistula; 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.; Other Names: FDA approved graft (various manufacturers)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients.	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	12 months
Functional cumulative patency rate at 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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Using Disease Outcomes Quality Initiative quality of life tool	2 years
To compare and analyze the estimated costs with both types of hemodialysis interventions and their postoperative outcomes.	Analysis of hospital bills to compare the costs with both types of hemodialysis interventions	2 years
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	Using Disease Outcomes Quality Initiative quality of life tool	2 years
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	Using Disease Outcomes Quality Initiative quality of life tool	2 years

Collaborators and Investigators

• Sponsor: E. Peden, MD
• Collaborators: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Eric K Peden, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2016
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: July 15, 2016
• First Submitted That Met QC Criteria: February 22, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: kidney disease; dialysis; hemodialysis; graft; vascular access; fistula
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
• Other Study ID Numbers: Pro00013220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Investigators plan to write a manuscript once all the participant information has been compiled.
• IPD Sharing Time Frame: Available for 5 years upon study completion
• IPD Sharing Access Criteria: After publication of results, de-identified participant data can be made available upon reasonable request to the Primary Investigator
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR