An observational study in End Stage Renal Disease and Hemodialysis Access Failure, sponsored by Mario Negri Institute for Pharmacological Research. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Mario Negri Institute for Pharmacological Research · Observational
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 AVG matures earlier than AVF (2/3 vs 6 weeks), but it is more prone to infections and has lower survival.
It would be important to identify patients at risk of VA failure, but there is currently a lack of adequate strategies for surveillance. A continuous monitoring of the VA function would help in identification of reduced blood flow and VA stenosis, that could be treated by interventional radiologists before AVF or AVG complete closure. Over the years, nurses and nephrologists got used to touch the VA and qualitatively evaluate its vibration, named "thrill", and the sounds emitted by the same using their stethoscope.
The purpose of this study is to assess the feasibility of VA sound recording and analysis and provide preliminary evidence of VA sound clinical validity and utility to assess, monitor and predict vascular remodelling occurring in AVFs and AVGs.
This is a single center prospective observational study involving the acquisition of VA sounds and Doppler US examinations in consenting patients with ESRD.
To reach this goal, two groups of ESRD patients in need of VA surgery to perform HD treatment will be involved:
Group 1. Patients with AVF as first line HD access option.
Group 2. Patients with AVG as first line HD access option.
2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.
This study's planned enrollment of 44 is below the median of 120 across 431 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Mario Negri Institute for Pharmacological Research is the lead sponsor of 159 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will be performed in patients with ESRD enrolled at the Nephrology and Dialysis Department of the ASST Papa Giovanni XXIII (Bergamo, Italy). VA sounds and Doppler US data will be collected.
The patients of both groups (AVF and AVG) will undergo visit V1 (screening and enrolment). On day 0 they will have the surgery for VA creation (V2). Then the study follow-up visits will be performed:
Patients will be asked to provide consent for the use of their clinical and laboratory data collected during routine clinical practice over 10 years following the end of this study. Refusal to this consent will not prevent from participating in the study.
Exclusion Criteria:
24 consecutive patients in need of AVF enrolled at the Nephrology and Dialysis unit of the ASST-Papa Giovanni XXIII of Bergamo.
Procedure: AVF creation
20 consecutive patients in need of AVG enrolled at the Nephrology and Dialysis unit of the ASST-Papa Giovanni XXIII of Bergamo.
Procedure: AVG creation
AVF is surgically created in the forearm by an anastomosis between a vein and an artery
Surgery is done using an artificial plastic tube that connects an artery to a vein
Low-high peak ratio (LHPR)
Ratio between the amplitude of maximum peak in the range of lowfrequency (100-250 Hz) and the amplitude of the maximum peak at high frequency (500-750 Hz).
Time frame: From v3 (day 7) to end visit (month 24): change from previous visit
Correlation coefficient between LHPR and Blood Flow Volume (BFV) during VA maturation.
BFV is measured with Doppler ultrasonography (US).
Time frame: From v3 (day 7) to VA maturation (v6, day 42): change from previous visit
Correlation coefficient between LHPR and Blood Flow Volume (BFV) after VA maturation.
BFV is measured with Doppler ultrasonography (US).
Time frame: From v7 (day 60) to end visit (month 24): change from previous visit
Plan to share: Undecided
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Mario Negri Institute for Pharmacological Research