Hemodialysis in the Elderly (70yrs & Older)

NCT03065972 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2023-08-14

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03065972 on ClinicalTrials.gov