Acoustic Analysis of VA Sounds

Sponsor
Mario Negri Institute for Pharmacological Research
Study ID
NCT05612022
Status
Recruiting
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Conditions

  • End Stage Renal Disease
  • Hemodialysis Access Failure

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Nov 10, 2022
Start date
May 9, 2023
Status verified
Nov 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
44 participants (estimated)

Arms

  • Arm: Group 1. Patients with AVF as first line HD access option.
    24 consecutive patients in need of AVF enrolled at the Nephrology and Dialysis unit of the ASST-Papa Giovanni XXIII of Bergamo.
  • Arm: Group 2. Patients with AVG as first line HD access option.
    20 consecutive patients in need of AVG enrolled at the Nephrology and Dialysis unit of the ASST-Papa Giovanni XXIII of Bergamo.

Primary Outcome Measure

Low-high peak ratio (LHPR) [ Time Frame: From v3 (day 7) to end visit (month 24): change from previous visit ]

Central Contacts

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