Analysis of sounds from vascular access in dialysis patients
Acoustic Analysis of Blood Flow-emitted Sounds to Detect Vascular Complications in Arteriovenous Fistulae and Grafts for Hemodialysis
Mario Negri Institute for Pharmacological Research · NCT05612022
This study is testing whether listening to the sounds from different types of vascular access can help doctors understand how well they work for patients on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Mario Negri Institute for Pharmacological Research (other) |
| Locations | 1 site (Bergamo, BG) |
| Trial ID | NCT05612022 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with end-stage renal disease (ESRD) who are undergoing hemodialysis and require a new vascular access (VA). It aims to analyze the acoustic properties of sounds generated by arteriovenous fistulas (AVF) and arteriovenous grafts (AVG) to better understand their functionality and potential failure rates. The study will include patients who are either currently on hemodialysis or in a pre-dialysis program, and will assess the effectiveness of different types of vascular access. The goal is to improve the management of vascular access in ESRD patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with end-stage renal disease who are currently on hemodialysis or are entering a pre-dialysis program and require a new vascular access.
Not a fit: Patients who are using catheters for hemodialysis, undergoing peritoneal dialysis, or have a life expectancy of less than two years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for monitoring and maintaining vascular access in hemodialysis patients, potentially reducing complications and improving patient outcomes.
How similar studies have performed: While the approach of acoustic analysis in vascular access is relatively novel, similar studies have shown promise in improving outcomes for patients with vascular access issues.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Bergamo, BG
- ASST HPG23 Unità di Nefrologia e Dialisi — Bergamo, BG, Italy (RECRUITING)
Study contacts
- Study coordinator: Anna Caroli
- Email: anna.caroli@marionegri.it
- Phone: 003903545351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: End Stage Renal Disease, Hemodialysis Access Failure, AVF, AVG, VA sounds, acoustic analysis, VA remodelling, Doppler Ultrasound