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

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ClinicalTrials.gov Identifier: NCT03065972
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
The Methodist Hospital System
Information provided by (Responsible Party):
E. Peden, MD, The Methodist Hospital System

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Disease Kidney Failure Chronic Kidney Disease Procedure: Surgical fistula creation from patient's anatomy Device: Surgical Graft implant Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Autologous Arteriovenous Fistulas Versus Hemodialysis Access Grafts in Elderly Patients
Study Start Date : February 2016
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: FDA approved graft (various manufacturers)




Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065972


Contacts
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Contact: Rachel Kronman-Gross, BS, CCRP 713-441-6539 rkronman-gross@houstonmethodist.org
Contact: Kim Donlon, RN 713-441-9394 kdonlon@houstonmethodist.org

Locations
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United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Rachel Kronman, BS, CCRP    713-441-6539    rkronman-gross@houstonmethodist.org   
Contact: Kim Donlon, RN    713-441-9394    kdonlon@houstonmethodist.org   
Principal Investigator: Eric Peden, MD         
Sub-Investigator: Carlos Bechara, MD         
Sub-Investigator: Linda Le, MD         
Sub-Investigator: Thomas Loh, MD         
Sponsors and Collaborators
E. Peden, MD
The Methodist Hospital System
Investigators
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Principal Investigator: Eric Peden, MD The Methodist Hospital System

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Responsible Party: E. Peden, MD, Sponsor-Investigator/Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT03065972     History of Changes
Other Study ID Numbers: Pro00013220
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The Investigators plan to write a manuscript once all the participant information has been compiled.

Keywords provided by E. Peden, MD, The Methodist Hospital System:
kidney disease
vascular access
graft
fistula
hemodialysis
dialysis

Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases