Acoustic Analysis of VA Sounds for Dialysis Patients
Acoustic Analysis of VA Sounds
Recruiting
Observational Study
End Stage Renal DiseaseHemodialysis Access Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 90
Sex
Any
Study type
Observational
Participants needed
44 (estimated)
Sponsor
Mario Negri Institute for Pharmacological Research · Other
Who this trial is looking for
This trial is looking for patients on hemodialysis who need a new access point for their blood flow or have recently started the pre-dialysis program due to kidney failure. Participants will be involved in monitoring the blood flow access to help improve treatment outcomes.
Are You a Good Fit for This Trial?
You may be able to join if
I can provide informed consent
I am on hemodialysis and need a new access point
I have entered the pre-dialysis program due to kidney failure
You may not be able to join if
I have contraindications for creating a new blood access point
I use a catheter for my hemodialysis
I am undergoing peritoneal dialysis
I have a life expectancy of less than 2 years
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 …
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.
Trial Locations
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Eligibility 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 autogeno…
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.
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