Clinical trial Recruiting at 1 site Observational Ages 18 to 90

Analysis of sounds from vascular access in dialysis patients

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

Run by Mario Negri Institute for Pharmacological Research · NCT05612022 · Data updated 2026-11-12

This study is testing whether listening to the sounds from different types of vascular access can help doctors understand how well they work for patients on dialysis.

More End Stage Renal Disease trials

Quick facts

Study typeObservational
Ages18 Years to 90 Years
SexAll
Enrollment44 (estimated)
SponsorMario Negri Institute for Pharmacological Research
Academic / other
Locations1 site (Bergamo, BG)
StatusRecruiting
StartedMay 9, 2023
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedNovember 29, 2024
Trial IDNCT05612022 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients with end-stage renal disease who are currently on hemodialysis or are entering a pre-dialysis program and require a new vascular access.

Probably not a fit

Patients who are using catheters for hemodialysis, undergoing peritoneal dialysis, or have a life expectancy of less than two years may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with end-stage renal disease (ESRD) who are undergoing hemodialysis and require a new vascular access (VA). It aims to analyze the acoustic properties of sounds generated by arteriovenous fistulas (AVF) and arteriovenous grafts (AVG) to better understand their functionality and potential failure rates. The study will include patients who are either currently on hemodialysis or in a pre-dialysis program, and will assess the effectiveness of different types of vascular access. The goal is to improve the management of vascular access in ESRD patients.

Why it matters

Potential benefit: If successful, this study could lead to improved strategies for monitoring and maintaining vascular access in hemodialysis patients, potentially reducing complications and improving patient outcomes.

How similar studies have gone: While the approach of acoustic analysis in vascular access is relatively novel, similar studies have shown promise in improving outcomes for patients with vascular access issues.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • ASST HPG23 Unità di Nefrologia e Dialisi
    Bergamo, Bg, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.