Recruiting

Observational Study

Sponsor:

E. Peden, MD

Code:

NCT03065972

Conditions

Kidney Disease

Kidney Failure

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Surgical fistula creation from patient's anatomy

Surgical Graft implant

Study Details

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.

Conditions

Kidney Disease

Kidney Failure

Chronic Kidney Disease

Study ID

NCT03065972

Start date

Jan 28, 2016

Status verified date

Aug, 2023

Completion date

Feb, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Surgical graft implant

Patients randomized to surgical graft, will have a commercially available graft surgically implanted to be used for hemodialysis access.

Interventions

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.

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.

Primary outcome measure

  • Analyze hemodialysis (HD) access creation, arteriovenous (AV) fistula vs Graft, in elderly patients. [ Time Frame: 12 months ]
  • Functional cumulative patency rate at 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Bright Benfor, MD

713-441-0147bbenfor@houstonmethodist.org

Bevin A Lopez, MS,CEP,CCRP

346-320-7421balopez@houstonmethodist.org

Locations

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Bright Benfor, MD

713-441-0147bbenfor@houstonmethodist.org

Bevin A Lopez, MS,CEP,CCRP

346-320-7421balopez@houstonmethodist.org

Principal Investigator:

Eric Peden, MD

More Information

Sponsor

E. Peden, MD

Last update posted

Aug 14, 2023

Last verified

Aug, 2023

Keywords

  • kidney disease
  • vascular access
  • graft
  • fistula
  • hemodialysis
  • dialysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by E. Peden, MD on 2023-08-14.