Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Point of care ultrasound | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline (within 6 hours of ICU admission), and at 24, 48, and 72 hours after ICU admission |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Federico Moro, MD | Contact | 0039 0516478215 | federico.moro@ausl.bologna.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Maggiore C.A. Pizzardi AUSL Bologna | Recruiting | Bologna | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007674 | Kidney Diseases |
| D020896 | Hypovolemia |
| D004487 | Edema |
| D051437 | Renal Insufficiency |
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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. | 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. | At hospital discharge (assessed up to hospital discharge, expected within 90 days after ICU admission) |
| 30-day ventilator-free days | 30-day after enrollment |
| Long-term renal function | (creatinine at 6 months ±2 weeks) | 6 months ±2 weeks after hospital discharge |
| D052801 | Male Urogenital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |