Hemodialysis in the Elderly (70yrs & Older)

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.

Conditions

Kidney Disease, Kidney Failure, Chronic Kidney Disease

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Study Overview

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Study Details

Study 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.

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

Hemodialysis in the Elderly (70yrs & Older)

Condition
Kidney Disease
Intervention / Treatment

-

Contacts and Locations

Houston

Houston Methodist Hospital, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

70 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

E. Peden, MD,

Eric K Peden, MD, PRINCIPAL_INVESTIGATOR, The Methodist Hospital Research Institute

Study Record Dates

2025-02