Skip to content

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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05612022
Acronym
VAsound
Enrollment
44
Registered
2022-11-10
Start date
2023-05-09
Completion date
2026-12-31
Last updated
2024-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Hemodialysis Access Failure

Keywords

AVF, AVG, VA sounds, acoustic analysis, VA remodelling, Doppler Ultrasound

Brief 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.

Interventions

PROCEDUREAVF creation

AVF is surgically created in the forearm by an anastomosis between a vein and an artery

PROCEDUREAVG creation

Surgery is done using an artificial plastic tube that connects an artery to a vein

Sponsors

Mario Negri Institute for Pharmacological Research
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Provision of informed consent prior to any study specific procedures. 2. 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

1. Contraindications for the creation of an autogenous AVF, for the AVG creation or the proximalization of a failed VA. 2. Patients who use catheter to perform HD. 3. Patients undergoing peritoneal dialysis. 4. Patients with life expectancy less than 2 years.

Design outcomes

Primary

MeasureTime frameDescription
Low-high peak ratio (LHPR)From v3 (day 7) to end visit (month 24): change from previous visitRatio 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

MeasureTime frameDescription
Correlation coefficient between LHPR and Blood Flow Volume (BFV) during VA maturation.From v3 (day 7) to VA maturation (v6, day 42): change from previous visitBFV is measured with Doppler ultrasonography (US).
Correlation coefficient between LHPR and Blood Flow Volume (BFV) after VA maturation.From v7 (day 60) to end visit (month 24): change from previous visitBFV is measured with Doppler ultrasonography (US).

Countries

Italy

Contacts

Primary ContactAnna Caroli
anna.caroli@marionegri.it003903545351
Backup ContactSofia Poloni
sofia.poloni@marionegri.it003903545351

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026