NCT05612022

Acoustic Analysis of VA Sounds

Acoustic Analysis of Blood Flow-emitted Sounds to Detect Vascular Complications in Arteriovenous Fistulae and Grafts for Hemodialysis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 44 (estimated)
• Sponsor: Mario Negri Institute for Pharmacological Research · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functioning vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. The current recommendation for VA is the native arteriovenous fistula (AVF), surgically created in the forearm by an anastomosis between a vein and an artery. The AVF, despite being the first-choice treatment, is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new VA. An arteriovenous graft (AVG) is the second choice for a VA. Surgery is done using an artificial plastic tube that connects an artery to a vein. The AVG matures earlier than AVF (2/3 vs 6 weeks), but it is more prone to infections and has lower survival. It would be important to identify patients at risk of VA failure, but there is currently a lack of adequate strategies for surveillance. A continuous monitoring of the VA function would help in identification of reduced blood flow and VA stenosis, that could be treated by interventional radiologists before AVF or AVG complete closure. Over the years, nurses and nephrologists got used to touch the VA and qualitatively evaluate its vibration, named "thrill", and the sounds emitted by the same using their stethoscope. The purpose of this study is to assess the feasibility of VA sound recording and analysis and provide preliminary evidence of VA sound clinical validity and utility to assess, monitor and predict vascular remodelling occurring in AVFs and AVGs. This is a single center prospective observational study involving the acquisition of VA sounds and Doppler US examinations in consenting patients with ESRD. To reach this goal, two groups of ESRD patients in need of VA surgery to perform HD treatment will be involved: Group 1. Patients with AVF as first line HD access option. Group 2. Patients with AVG as first line HD access option.

Conditions

• End Stage Renal Disease
• Hemodialysis Access Failure

Interventions

Type	Name	Description
PROCEDURE	AVF creation	AVF is surgically created in the forearm by an anastomosis between a vein and an artery
PROCEDURE	AVG creation	Surgery is done using an artificial plastic tube that connects an artery to a vein

Timeline

• Start date: 2023-05-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-11-10
• Last updated: 2024-11-29

Locations

1 site across 1 country: Italy