End Stage Renal DiseaseVAsoundNCT05612022
Acoustic Analysis of VA Sounds
An observational study of End Stage Renal Disease and Hemodialysis Access Failure, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- End Stage Renal Disease, Hemodialysis Access Failure
- What is being tested?
- AVF creation and AVG creation
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 9 May 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST HPG23 Unità di Nefrologia e Dialisi
Bergamo, BG, 24127
Carmela Giuseppina Condemi, MD, 0039 035 2673992, ccondemi@asst-pg23.it
Patrizia Ondei, MD, pondei@asst-pg23.it
About this study
Official title: 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.
Read more
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.
- Being tested
- AVF creation, AVG creation
- Keywords
- AVF, AVG, VA sounds, acoustic analysis, VA remodelling, Doppler Ultrasound
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVF creationProcedure or surgery
AVF is surgically created in the forearm by an anastomosis between a vein and an artery
AVG creationProcedure or surgery
Surgery is done using an artificial plastic tube that connects an artery to a vein
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 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. Receives: Procedure: AVG creation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-high peak ratio (LHPR)
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).
Measured: From v3 (day 7) to end visit (month 24): change from previous visit
Secondary outcomes (2)
Correlation coefficient between LHPR and Blood Flow Volume (BFV) during VA maturation.
BFV is measured with Doppler ultrasonography (US).
Measured: 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.
BFV is measured with Doppler ultrasonography (US).
Measured: From v7 (day 60) to end visit (month 24): change from previous visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start9 May 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05612022
- Sponsor's protocol ID
- VAsound
- Acronym
- VAsound
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acoustic Analysis of Blood Flow-emitted Sounds to Detect Vascular Complications in Arteriovenous Fistulae and Grafts for Hemodialysis
- ClinicalTrials.gov ID
- NCT05612022
- Acronym / sponsor ID
- VAsound / VAsound
- Keywords
- AVF, AVG, VA sounds, acoustic analysis, VA remodelling, Doppler Ultrasound
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1. Patients with AVF as first line HD access option. | – | Procedure: AVF creation24 consecutive patients in need of AVF enrolled at the Nephrology and Dialysis unit of the ASST-Papa Giovanni XXIII of Bergamo. |
| Group 2. Patients with AVG as first line HD access option. | – | Procedure: AVG creation20 consecutive patients in need of AVG enrolled at the Nephrology and Dialysis unit of the ASST-Papa Giovanni XXIII of Bergamo. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVF creationAVF is surgically created in the forearm by an anastomosis between a vein and an artery | Procedure or surgery | Group 1. Patients with AVF as first line HD access option. |
| AVG creationSurgery is done using an artificial plastic tube that connects an artery to a vein | Procedure or surgery | Group 2. Patients with AVG as first line HD access option. |
Primary outcome
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).
2 secondary outcomes
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease and Hemodialysis Access Failure, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Caroli (003903545351, anna.caroli@marionegri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-high peak ratio (LHPR) (time frame: From v3 (day 7) to end visit (month 24): change from previous visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024; AzTrials last refreshed its copy on 6 Nov 2026.