Optimising Access Surgery in Senior Haemodialysis Patients (OASIS): study protocol for a multicentre randomised...

Area of Science:

• Nephrology
• Vascular Surgery
• Geriatrics

Background:

• Observational studies on vascular access strategies for hemodialysis patients are limited by selection bias.
• Autologous arteriovenous fistulas may not be optimal for elderly patients due to maturation failure.
• Long-term complications of grafts and catheters may be less relevant for patients with limited life expectancy.

Purpose of the Study:

• To determine the best vascular access strategy for elderly hemodialysis patients.
• To compare fistula creation, graft placement, and catheter insertion in patients aged 70 years or older.
• To reduce the number of access-related interventions in this demographic.

Main Methods:

• A multicenter, randomized controlled trial (OASIS trial) with equal participant allocation into three arms.
• Enrollment of patients aged 70 years or older awaiting or starting hemodialysis.
• Primary outcome: number of access-related interventions per patient-year of hemodialysis treatment.

Main Results:

• The study is designed to enroll 195 patients.
• Sufficient statistical power to detect an absolute decrease of 0.80 interventions per year.
• The primary outcome will be analyzed to compare the three vascular access strategies.

Conclusions:

• Clinical equipoise justifies random allocation of elderly patients to different vascular access strategies.
• The study findings will be disseminated through peer-reviewed publications.
• Results will inform updates to clinical practice guidelines for vascular access in elderly hemodialysis patients.