Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05612022

Acoustic Analysis of VA Sounds

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of informed consent prior to any study specific procedures.
  • Patients in HD treatment that need a new VA or patients that entered the pre-dialysis program because of ESRD. In all these cases the treatment of first choice should be the creation of a distal autogenous AVF, the creation of an AVG or the proximalization of an occluded VA.

Exclusion criteria

  • Contraindications for the creation of an autogenous AVF, for the AVG creation or the proximalization of a failed VA.
  • Patients who use catheter to perform HD.
  • Patients undergoing peritoneal dialysis.
  • Patients with life expectancy less than 2 years.

Treatment and study plan

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

Primary outcomes

  1. Low-high peak ratio (LHPR)

    Time frame: From v3 (day 7) to end visit (month 24): change from previous visit

    Ratio between the amplitude of maximum peak in the range of lowfrequency (100-250 Hz) and the amplitude of the maximum peak at high frequency (500-750 Hz).

Secondary outcomes

  1. Correlation coefficient between LHPR and Blood Flow Volume (BFV) during VA maturation.

    Time frame: From v3 (day 7) to VA maturation (v6, day 42): change from previous visit

    BFV is measured with Doppler ultrasonography (US).

  2. Correlation coefficient between LHPR and Blood Flow Volume (BFV) after VA maturation.

    Time frame: From v7 (day 60) to end visit (month 24): change from previous visit

    BFV is measured with Doppler ultrasonography (US).

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Caroli

CONTACT

[email protected]

003903545351

Sofia Poloni

CONTACT

[email protected]

003903545351

Sponsors and collaborators

Lead sponsor

Mario Negri Institute for Pharmacological Research

Other

Registry information

Official study title

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

Acronym: VAsound

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 10, 2022
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.