Acoustic Analysis of VA Sounds
Launched by MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH · Nov 3, 2022
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a new way to monitor vascular access (VA) sounds in patients with end-stage renal disease (ESRD) who need hemodialysis (HD). The study aims to see if recording and analyzing the sounds from the VA—where blood is accessed for dialysis—can help doctors detect problems before they become serious. Currently, many patients experience issues with their vascular access, leading to the need for new surgeries. By identifying patients at risk of access failure, healthcare providers can intervene early and potentially prevent complications.
To participate in this study, patients must be between the ages of 65 and 87 and need a new vascular access for hemodialysis. They should be able to give informed consent and have not had any major contraindications that would prevent the creation of a vascular access. Participants will undergo sound recording and ultrasound examinations of their vascular access while receiving treatment. This study is a single center observational study, meaning it will take place at one location and will focus on collecting information to help improve future care for patients needing vascular access for dialysis.
Gender
ALL
Eligibility 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.
About Mario Negri Institute For Pharmacological Research
The Mario Negri Institute for Pharmacological Research is a leading Italian biomedical research organization dedicated to advancing pharmacological science and improving public health. Established in 1963, the Institute focuses on innovative research methodologies, drug development, and clinical trials aimed at understanding and treating various diseases. With a multidisciplinary team of scientists and clinicians, the Institute collaborates with national and international partners to translate research findings into clinical applications, contributing significantly to the fields of pharmacology, epidemiology, and biostatistics. Committed to excellence in research and ethical standards, the Mario Negri Institute plays a vital role in shaping the future of medical science and enhancing therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bergamo, Bg, Italy
Bergamo, Bg, Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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