Renal and Hepatic Abnormal Doppler Patterns in Trauma (RECREANT)

Renal and hEpatiC abnoRmal dopplEr pAtterns iN Trauma: a Multicentre Prospective Observational Study

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Failure; Hypovolemia; Kidney Disease; Hypervolemia; Trauma (Including Fractures); Trauma Patients
• Intervention / Treatment: Diagnostic test: Point of care ultrasound

• Study Type: Observational
• Enrollment (Estimated): 350

Contacts and Locations

• Study Contact: Name: Federico Moro, MD; Phone Number: 0039 0516478215; Email: federico.moro@ausl.bologna.it

Study Locations

• Italy
  • Bologna, Italy
    • Recruiting
    • Ospedale Maggiore C.A. Pizzardi AUSL Bologna
    • Sub-Investigator: Marco Tartaglione, MD
    • Contact: Federico Moro, MD; Phone Number: 0039 0516478215; Email: federico.moro@ausl.bologna.it
    • Principal Investigator: Lorenzo Gamberini, MD
    • Sub-Investigator: Valentina Chiarini, MD
    • Sub-Investigator: Federico Moro, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Azienda Usl di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: trauma; ICU; kidney failure; major trauma; renal perfusion; kidney injury; Venous congestion; VEXUS; Renal Doppler resistive index; Hemodynamic phenotyping
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Wounds and Injuries; Renal Insufficiency; Kidney Diseases; Edema; Hypovolemia; Hyperemia
• Other Study ID Numbers: 665-2025-OSS-AUSLBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No