Kidney and liver blood flow patterns after major trauma
Renal and hEpatiC abnoRmal dopplEr pAtterns iN Trauma: a Multicentre Prospective Observational Study
We will use bedside ultrasound to see whether abnormal kidney and liver blood flow patterns occur in adults admitted to the ICU after major trauma and whether those patterns link to acute kidney injury or the need for mechanical ventilation.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Azienda Usl di Bologna Government |
| Locations | 1 site (Bologna) |
| Trial ID | NCT07492511 on ClinicalTrials.gov |
What this trial studies
This is an observational study of adults (18–65) with major trauma (ISS >15) admitted to ICU or high-dependency units at a single center in Bologna. Trained operators will perform non-invasive bedside Doppler ultrasound to measure renal Doppler indices and a venous congestion score (RDRI and VExUS) at admission and at 24, 48, and 72 hours. The study will examine how common abnormal kidney and liver flow patterns are in the first 72 hours, the consistency of measurements between operators and sites, and whether those patterns are associated with acute kidney injury or need for mechanical ventilation. Kidney function will also be checked at 6 months after discharge to capture longer-term outcomes.
Who should consider this trial
Good fit: Adults aged 18–65 with major trauma (Injury Severity Score >15) admitted within 24 hours to the ICU or HDU, without chronic heart failure, chronic kidney disease, chronic respiratory support, or renal injuries on CT that prevent Doppler assessment, are ideal candidates.
Not a fit: People under 18 or over 65, those with known heart failure (NYHA ≥II), chronic kidney disease or chronic dialysis, chronic respiratory disease requiring home oxygen or ventilation, or radiologic renal injury that prevents Doppler assessment are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the findings could help clinicians identify early blood flow changes after trauma that predict kidney injury or respiratory support needs, enabling closer monitoring or earlier intervention.
How similar studies have performed: Prior single-center observational studies have suggested VExUS and renal Doppler relate to venous congestion and risk of AKI, but multicenter reliability and application specifically in major trauma patients remain less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bologna
- Ospedale Maggiore C.A. Pizzardi AUSL Bologna — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Federico Moro, MD
- Email: federico.moro@ausl.bologna.it
- Phone: 0039 0516478215
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.