Blood Flow Conditions and Sounds in AVFs

Launched by MARIO NEGRI INSTITUTE FOR PHARMACOLOGICAL RESEARCH · May 8, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Blood Flow Conditions and Sounds in AVFs," is designed to study how the flow of blood and the sounds made by a special type of access called an arteriovenous fistula (AVF) relate to each other in patients with end-stage renal disease (ESRD). An AVF is a surgical connection made between an artery and a vein in the arm, which is commonly used for dialysis treatment. The goal of the study is to learn if these sounds can help predict how well the AVF will work for patients who need it for their treatment.

To participate in this trial, individuals must be between 18 and 90 years old and either currently undergoing hemodialysis (HD) who need a new access point or those entering a pre-dialysis program due to kidney failure. Participants should be able to provide informed consent and should not have any conditions that would prevent the creation of an AVF or pose safety concerns during the study. Those who are pregnant, have certain medical devices, or are receiving other types of dialysis will not be eligible. If you join the study, you can expect to have your blood flow and the sounds of your AVF monitored, which could help improve future treatments for patients with kidney disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provision of informed consent prior to any study specific procedures.
• • Female and/or male aged between 18 and 90 years.
• • Patients in HD treatment who need a new VA or patients who entered the pre-dialysis program because of ESRD. In all cases, the first-choice treatment is the surgical creation of an autogenous AVF in patient's forearm.
• Exclusion Criteria:
• • Contraindications for the creation of an autogenous AVF.
• • Presence of a previously failed AVF in the same arm selected for surgery.
• • Patients with contraindications to MRI including: pregnancy, claustrophobia, cardiac pacemakers or other MRI-incompatible prostheses.
• • Patients already on HD treatment through a catheter or a graft.
• • Patients undergoing peritoneal dialysis.
• • Patients with a life expectancy of less than 2 years.