Acoustic Analysis of VA Sounds

End Stage Renal Disease Clinical Trial

— VAsound  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05612022
• Other study ID #: VAsound
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Mario Negri Institute for Pharmacological Research
• Contact: Anna Caroli
• Phone: 003903545351
• Email: anna.caroli[@]marionegri.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hemodialysis Access Failure
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Italy	ASST HPG23 Unità di Nefrologia e Dialisi	Bergamo	BG

Sponsors (1)

Lead Sponsor	Collaborator
Mario Negri Institute for Pharmacological Research

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-high peak ratio (LHPR)	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).	From v3 (day 7) to end visit (month 24): change from previous visit
Secondary	Correlation coefficient between LHPR and Blood Flow Volume (BFV) during VA maturation.	BFV is measured with Doppler ultrasonography (US).	From v3 (day 7) to VA maturation (v6, day 42): change from previous visit
Secondary	Correlation coefficient between LHPR and Blood Flow Volume (BFV) after VA maturation.	BFV is measured with Doppler ultrasonography (US).	From v7 (day 60) to end visit (month 24): change from previous visit