Hemodialysis in the Elderly (70yrs & Older)
NCT03065972 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270
Last updated 2023-08-14
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.
Conditions
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.
Sponsors & Collaborators
-
The Methodist Hospital Research Institute
collaborator OTHER -
E. Peden, MD
lead OTHER
Principal Investigators
-
Eric K Peden, MD · The Methodist Hospital Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-28
- Primary Completion
- 2025-02-28
- Completion
- 2025-02-28
Countries
- United States
Study Locations
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