Renal and Hepatic Abnormal Doppler Patterns in Trauma

NCT07492511 | Recruiting

• 1 other identifier: 665-2025-OSS-AUSLBO
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma (Including Fractures); Trauma Patients; Kidney Disease; Hypovolemia; Hypervolemia; Kidney Failure

Keywords

VEXUS; trauma; kidney injury; kidney failure; Venous congestion; renal perfusion; Renal Doppler resistive index; major trauma; Hemodynamic phenotyping; ICU

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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

• Acute kidney injury severity according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria

  From enrollment up to 7 days after ICU admission

• Persistent acute kidney injury according to KDIGO criteria

  From 48 hours after AKI onset up to 7 days after ICU admission

• 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)

• 30-day ventilator-free days

  30-day after enrollment

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Age 18-65 years;
• Admission within 24h from traumatic injury;
• ISS \>15

You may not qualify if:

• Age \<18 or \>65;
• Known heart failure (NYHA ≥II);
• Chronic kidney disease (any stage) or chronic RRT;
• Chronic respiratory disease needing home O₂ or ventilation;
• Radiological evidence of vascular or parenchymal renal injury on trauma CT precluding reliable Doppler assessment

Sponsors & Collaborators

• Azienda Usl di Bologna: lead

Study Sites (1)

Ospedale Maggiore C.A. Pizzardi AUSL Bologna

Bologna, Italy

RECRUITING

MeSH Terms

Conditions

Wounds and Injuries; Kidney Diseases; Hypovolemia; Edema; Renal Insufficiency; Hyperemia

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Federico Moro, MD

CONTACT

0039 0516478215; federico.moro@ausl.bologna.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

IT (1)