Listening to Sounds from Dialysis Access Vessels in Kidney Patients
Records and analyzes sounds from dialysis access vessels in adults with kidney failure.
Key facts
- Who runs it
- Mario Negri Institute for Pharmacological Research
- Where
- Bergamo, ItalySee the site
- Trial code
- Registry title
- Acoustic Analysis of VA Sounds
- Status
- Recruiting
- People taking part
- 44 people, planned
- Started
- 9 May 2023
- Expected to end
- Dec 2026
- Type of study
- Observational, 2 groups
- Treatments tested
- AVF creation
- AVG creation
- Record updated
- 29 November 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with end-stage kidney disease who need a new vascular access for hemodialysis. Researchers will record the sounds of the access.
- Age
- 18 Years to 90 Years
- Sex
- All sexes can join.
- Disease stage
- End-stage kidney disease, either already on hemodialysis and needing a new vascular access, or in the pre-dialysis program.
- Earlier treatment
- People who use a catheter for hemodialysis cannot join. People on peritoneal dialysis cannot join.
Main reasons for not taking part
- Cannot have an arteriovenous fistula, an arteriovenous graft or proximalization of a failed access created
- Uses a catheter for hemodialysis
- On peritoneal dialysis
- Life expectancy of less than 2 years
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 90 years old?
Where in Italy
- ASST HPG23 Unità di Nefrologia e DialisiBergamo, ItalyContact: Carmela Giuseppina Condemi, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- 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.
Treatment: AVF creation
- 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.
Treatment: AVG creation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Acoustic Analysis of Blood Flow-emitted Sounds to Detect Vascular Complications in Arteriovenous Fistulae and Grafts for Hemodialysis
- Plain-language title
- Listening to Sounds from Dialysis Access Vessels in Kidney PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT05612022, who can take part
- Record updated
- 29 November 2024