Actively Recruiting
Acoustic Analysis of Blood Flow-emitted Sounds to Detect Vascular Complications in Arteriovenous Fistulae and Grafts for Hemodialysis
Led by Mario Negri Institute for Pharmacological Research · Updated on 2024-11-29
44
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
This research focuses on patients with end-stage renal disease (ESRD), a condition affecting many people worldwide, especially as populations age and patients live longer on renal replacement therapy. Most patients with ESRD undergo hemodialysis (HD), which requires a reliable vascular access (VA) such as an arteriovenous fistula (AVF) or an arteriovenous graft (AVG). The study aims to evaluate the use of vascular access sound recordings and analysis to monitor VA function and predict complications like stenosis or failure, helping to improve patient outcomes. The study involves two groups of ESRD patients needing VA surgery for hemodialysis: one group receiving AVF creation, where a vein and artery are surgically connected in the forearm, and another receiving AVG creation, which uses an artificial plastic tube to connect an artery to a vein. This is a prospective observational study where VA sounds and Doppler ultrasound examinations will be collected over time to assess vascular remodeling and access function. Participants will have their vascular access sounds recorded and undergo ultrasound exams from day 7 after surgery up to 24 months. Researchers will monitor changes in sound characteristics and blood flow volume to evaluate VA maturation and function. The primary outcome measure is the low-high peak ratio (LHPR) of the sound, tracked over the study period. This approach aims to provide a non-invasive method to predict VA complications and improve management in ESRD patients on hemodialysis.
CONDITIONS
Brief Title
Acoustic Analysis of VA Sounds
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provision of informed consent prior to any study specific procedures.
- Patients on hemodialysis treatment needing a new vascular access, or patients in pre-dialysis program because of end-stage renal disease.
- First choice treatment should be creation of a distal autogenous arteriovenous fistula, an arteriovenous graft, or proximalization of an occluded vascular access.
You will not qualify if you...
- Contraindications for creation of an autogenous arteriovenous fistula, arteriovenous graft, or proximalization of a failed vascular access.
- Patients using catheter for hemodialysis.
- Patients undergoing peritoneal dialysis.
- Patients with life expectancy less than 2 years.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day 0
Participants undergo surgery to create a vascular access using either an arteriovenous fistula or an arteriovenous graft.
1 surgery visit (in-person)
Duration - From day 7 to month 24
Participants are monitored through acoustic analysis of blood flow-emitted sounds and blood flow volume measurements to detect vascular complications and assess maturation of the vascular access.
Multiple visits from day 7 to month 24, including visits at day 7, day 42, day 60, and monthly assessments up to month 24
Trial Site Locations
Total: 1 location
1
ASST HPG23 Unità di Nefrologia e Dialisi
Bergamo, BG, Italy, 24127
Actively Recruiting
Research Team
A
Anna Caroli
S
Sofia Poloni
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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