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

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.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

Trial Eligibility

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 Info

Interventions

Locations Recruiting

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