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NCT Number: NCT07492511

Renal and Hepatic Abnormal Doppler Patterns in Trauma

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.

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Key information

Conditions

Trauma (Including Fractures) Cardiovascular Diseases Edema Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperemia Hypervolemia Hypovolemia Kidney Disease Kidney Diseases Kidney Failure Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Trauma Patients Urogenital Diseases Urologic Diseases Vascular Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale Maggiore C.A. Pizzardi AUSL Bologna

Bologna, Italy

Location status: Recruiting

Location contact

Federico Moro, MD

CONTACT

[email protected]

0039 0516478215

Federico Moro, MD

SUB_INVESTIGATOR

Lorenzo Gamberini, MD

PRINCIPAL_INVESTIGATOR

Marco Tartaglione, MD

SUB_INVESTIGATOR

Valentina Chiarini, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Distribution of renal arterio-venous Doppler phenotypes assessed using Renal Doppler Resistive Index (RDRI) and intrarenal venous Doppler flow patterns

    Time frame: 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 outcomes

  1. Distribution of Venous Excess Ultrasound (VExUS) scores

    Time frame: 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.

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

    Time frame: 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.

  3. Persistent acute kidney injury according to KDIGO criteria

    Time frame: 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.

  4. Acute kidney injury at hospital discharge according to KDIGO criteria

    Time frame: 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.

  5. 30-day ventilator-free days

    Time frame: 30-day after enrollment

  6. Long-term renal function

    Time frame: 6 months ±2 weeks after hospital discharge

    (creatinine at 6 months ±2 weeks)

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Moro, MD

CONTACT

[email protected]

0039 0516478215

Sponsors and collaborators

Lead sponsor

Azienda Usl di Bologna

Other Gov

Registry information

Official study title

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

Acronym: RECREANT

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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