Acoustic Analysis of VA Sounds (VAsound)
Acoustic Analysis of Blood Flow-emitted Sounds to Detect Vascular Complications in Arteriovenous Fistulae and Grafts for Hemodialysis
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Anna Caroli
- Phone Number: 003903545351
- Email: anna.caroli@marionegri.it
Study Contact Backup
- Name: Sofia Poloni
- Phone Number: 003903545351
- Email: sofia.poloni@marionegri.it
Study Locations
-
-
BG
-
Bergamo, BG, Italy, 24127
- Recruiting
- ASST HPG23 Unità di Nefrologia e Dialisi
-
Contact:
- Carmela Giuseppina Condemi, MD
- Phone Number: 0039 035 2673992
- Email: ccondemi@asst-pg23.it
-
Contact:
- Patrizia Ondei, MD
- Email: pondei@asst-pg23.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
The study will be performed in patients with ESRD enrolled at the Nephrology and Dialysis Department of the ASST Papa Giovanni XXIII (Bergamo, Italy). VA sounds and Doppler US data will be collected.
The patients of both groups (AVF and AVG) will undergo visit V1 (screening and enrolment). On day 0 they will have the surgery for VA creation (V2). Then the study follow-up visits will be performed:
- At 7, 14, 28, 42 and 60 days after VA surgery (V3, V4, V5, V6, V7)
- Once every 3 months from the third month to two years after VA surgery (V8, …, ENDV).
Patients will be asked to provide consent for the use of their clinical and laboratory data collected during routine clinical practice over 10 years following the end of this study. Refusal to this consent will not prevent from participating in the study.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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 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.
|
Surgery is done using an artificial plastic tube that connects an artery to a vein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Low-high peak ratio (LHPR)
Time Frame: From v3 (day 7) to end visit (month 24): change from previous visit
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation coefficient between LHPR and Blood Flow Volume (BFV) during VA maturation.
Time Frame: From v3 (day 7) to VA maturation (v6, day 42): change from previous visit
|
BFV is measured with Doppler ultrasonography (US).
|
From v3 (day 7) to VA maturation (v6, day 42): change from previous visit
|
|
Correlation coefficient between LHPR and Blood Flow Volume (BFV) after VA maturation.
Time Frame: From v7 (day 60) to end visit (month 24): change from previous visit
|
BFV is measured with Doppler ultrasonography (US).
|
From v7 (day 60) to end visit (month 24): change from previous visit
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAsound
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.