Hypervolemia, Hypovolemia, Kidney Disease, Kidney Failure, Trauma (Including Fractures), Trauma Patients
Conditions
Keywords
VEXUS, trauma, kidney injury, kidney failure, Venous congestion, renal perfusion, Renal Doppler resistive index, major trauma, Hemodynamic phenotyping, ICU
Brief summary
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: * How reliably can trained operators measure renal Doppler and venous congestion scores (RDRI and VExUS) across different hospitals? * How common are abnormal kidney and liver blood flow patterns in major trauma patients during the first 72 hours of ICU admission? * Are these abnormal patterns associated with acute kidney injury or the need for mechanical ventilation? 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.
Interventions
DIAGNOSTIC_TESTPoint of care ultrasound
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.
Sponsors
Azienda Usl di Bologna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years; * Admission within 24h from traumatic injury; * ISS \>15
Exclusion criteria
1. Age \<18 or \>65; 2. Known heart failure (NYHA ≥II); 3. Chronic kidney disease (any stage) or chronic RRT; 4. Chronic respiratory disease needing home O₂ or ventilation; 5. Radiological evidence of vascular or parenchymal renal injury on trauma CT precluding reliable Doppler assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of renal arterio-venous Doppler phenotypes assessed using Renal Doppler Resistive Index (RDRI) and intrarenal venous Doppler flow patterns | At baseline (within 6 hours of ICU admission), and at 24, 48, and 72 hours after ICU admission | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distribution of Venous Excess Ultrasound (VExUS) scores | At baseline (within 6 hours of ICU admission), and at 24, 48, and 72 hours after ICU admission | 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. |
| Acute kidney injury severity according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria | From enrollment up to 7 days after ICU admission | 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. |
| Persistent acute kidney injury according to KDIGO criteria | From 48 hours after AKI onset up to 7 days after ICU admission | 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. |
| Acute kidney injury at hospital discharge according to KDIGO criteria | At hospital discharge (assessed up to hospital discharge, expected within 90 days after ICU admission) | 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. |
| 30-day ventilator-free days | 30-day after enrollment | — |
| Long-term renal function | 6 months ±2 weeks after hospital discharge | (creatinine at 6 months ±2 weeks) |
Countries
Italy
Contacts
CONTACTFederico Moro, MD
Outcome results
None listed