ClinConnect ClinConnect Logo
Search / Trial NCT05612022

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

Avf Avg Va Sounds Acoustic Analysis Va Remodelling Doppler Ultrasound

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.

Locations

Bergamo, Bg, Italy

Bergamo, Bg, Italy

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials