An observational study in Trauma (Including Fractures), Trauma Patients and Kidney Disease, sponsored by Azienda Usl di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Azienda Usl di Bologna · Observational
The goal of this observational study is to learn about renal and hepatic blood flow abnormalities detected by bedside ultrasound in adult patients admitted to the intensive care unit (ICU) following major trauma.
The main questions it aims to answer are:
Participants admitted to ICUs or high-dependency units (HDUs) with major trauma (Injury Severity Score >15) will undergo non-invasive bedside ultrasound assessments at admission and at 24, 48, and 72 hours. No additional treatments or interventions will be given as part of this study. Kidney function will also be checked at 6 months after hospital discharge.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 350 is above the median of 169 across 690 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Azienda Usl di Bologna is the lead sponsor of 43 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients (aged 18-65 years) admitted to intensive care units (ICUs) or high-dependency units (HDUs) at participating centres following major trauma, defined as an Injury Severity Score (ISS) greater than 15, within 24 hours of the traumatic event. Patients with pre-existing chronic kidney disease, heart failure (NYHA ≥ II), chronic respiratory disease requiring home oxygen or ventilation, or radiological evidence of renal vascular or parenchymal injury precluding reliable Doppler assessment will be excluded.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Non-invasive bedside ultrasound assessment (renal Doppler and VExUS score) performed at baseline (≤6h from ICU admission), 24h, 48h, and 72h. No intervention is administered.
Distribution of renal arterio-venous Doppler phenotypes assessed using Renal Doppler Resistive Index (RDRI) and intrarenal venous Doppler flow patterns
Renal arterio-venous Doppler phenotypes will be classified into six predefined categories based on the combination of Renal Doppler Resistive Index (RDRI) and intrarenal venous Doppler flow patterns (continuous, biphasic, monophasic), as assessed by bedside Doppler ultrasonography.
Time frame: At baseline (within 6 hours of ICU admission), and at 24, 48, and 72 hours after ICU admission
Distribution of Venous Excess Ultrasound (VExUS) scores
Venous Excess Ultrasound (VExUS) score will be assessed using inferior vena cava diameter and Doppler evaluation of hepatic, portal, and renal veins. The VExUS grading system ranges from Grade 0 (no congestion) to Grade 3 (severe congestion), with higher scores indicating greater systemic venous congestion. Results will be reported as the proportion of patients in each VExUS category at each time point.
Time frame: At baseline (within 6 hours of ICU admission), and at 24, 48, and 72 hours after ICU admission
Acute kidney injury severity according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Acute kidney injury (AKI) severity will be classified according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria (Stages 1-3), based on serum creatinine and urine output. Higher stages indicate more severe kidney injury. The worst KDIGO stage reached within the first 7 days after ICU admission will be recorded.
Time frame: From enrollment up to 7 days after ICU admission
Persistent acute kidney injury according to KDIGO criteria
Persistent acute kidney injury (AKI) is defined as KDIGO Stage ≥1 lasting for at least 48 hours. AKI will be classified according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria (Stages 1-3), with higher stages indicating more severe kidney injury.
Time frame: From 48 hours after AKI onset up to 7 days after ICU admission
Acute kidney injury at hospital discharge according to KDIGO criteria
Acute kidney injury (AKI) at hospital discharge will be defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria as Stage ≥1 at the time of hospital discharge, based on serum creatinine and urine output.
Time frame: At hospital discharge (assessed up to hospital discharge, expected within 90 days after ICU admission)
30-day ventilator-free days
Time frame: 30-day after enrollment
Long-term renal function
(creatinine at 6 months ±2 weeks)
Time frame: 6 months ±2 weeks after hospital discharge
Plan to share: Undecided
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Azienda Usl di Bologna