Optimizing Access Surgery In Senior Hemodialysis Patients — OASIS  

Arteriovenous Fistula Clinical Trial

Official title: Optimizing Access Surgery In Senior Hemodialysis Patients: a Multicenter Randomized Controlled Trial of Fistulas, Grafts, and Catheters

Status Recruiting

Clinical Trial Summary

The number of elderly hemodialysis patients is growing. Vascular access complications are a major determinant of the quality of life and health care costs for these vulnerable patients. The three different types of vascular access, i.e. autologous arteriovenous fistulas, arteriovenous grafts, and central venous catheters, have never been compared in randomized controlled trials. This project will deliver the much-needed evidence to determine the optimal strategy for vascular access creation in elderly hemodialysis patients in order to deliver better health care at lower costs.

Clinical Trial Description

Objective: To compare surgical strategies for vascular access creation in elderly hemodialysis patients.

Hypothesis: Arteriovenous grafts and central venous catheters lead to fewer interventions, more quality of life, and lower health care costs than autologous arteriovenous fistulas.

Study design: Parallel group, multicenter randomized controlled trial.

Study population: Patients >65 years with a life expectancy <2 years who are expected to start hemodialysis treatment within 6 months or who have started hemodialysis treatment with a catheter in the past 6 months.

Study groups:

1. Autologous arteriovenous fistula creation

2. Arteriovenous graft implantation

3. Central venous catheter placement

Sample size calculation: 3x65 patients for superiority with multiplicity correction based on a clinically relevant difference of 0.80 interventions/year.

Data analysis: Poisson regression analysis with time as off-set variable. ;

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Arteriovenous Graft
• Central Venous Catheter Related Bloodstream Infection
• Dialysis Access Malfunction
• Fistula
• Hemodialysis Access Failure
• Sepsis
• Vascular Access Complication

• NCT number: NCT05911451
• Study type: Interventional
• Source: Maastricht University Medical Center
• Contact: Maarten G Snoeijs, MD PhD
• Phone: 0031625097694
• Email: maarten.snoeijs@mumc.nl
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Completion date: May 1, 2025