Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
44 participants
OBSERVATIONAL
2023-05-09
2026-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
AVF creation
AVF is surgically created in the forearm by an anastomosis between a vein and an artery
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.
AVG creation
Surgery is done using an artificial plastic tube that connects an artery to a vein
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
2. Patients who use catheter to perform HD.
3. Patients undergoing peritoneal dialysis.
4. Patients with life expectancy less than 2 years.
18 Years
90 Years
ALL
No
Sponsors
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Mario Negri Institute for Pharmacological Research
OTHER
Responsible Party
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Locations
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ASST HPG23 Unità di Nefrologia e Dialisi
Bergamo, BG, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VAsound
Identifier Type: -
Identifier Source: org_study_id