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Acoustic Analysis of VA Sounds

Recruitingn/aAges 18 Years - 90 YearsAllMario Negri Institute for Pharmacological Research
NCT05612022 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

End-stage renal disease (ESRD) is a growing global health problem, strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy. The majority of ESRD patients is on hemodialysis (HD) treatment. A successful HD procedure requires a functioning vascular access (VA) to provide safe and long-lasting way to connect patient circulation to the artificial kidney. The current recommendation for VA is the native arteriovenous fistula (AVF), surgically created in the forearm by an anastomosis between a vein and an artery. The AVF, despite being the first-choice treatment, is still affected by high non-maturation and early failure rates, requiring in most of the cases, the creation of a new VA. An arteriovenous graft (AVG) is the second choice for a VA. Surgery is done using an artificial plastic tube that connects an artery to a vein. The

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📋 Eligibility rules (as published)
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.
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What it tests

  • AVF creation
  • AVG creation
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Where

1 site
ASST HPG23 Unità di Nefrologia e Dialisi
Bergamo, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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