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Clinical Trial NCT07492511 (RECREANT) for Trauma (Including Fractures), Trauma Patients, Kidney Disease, Hypovolemia, Hypervolemia, Kidney Failure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Renal and Hepatic Abnormal Doppler Patterns in Trauma (RECREANT) 350 Non-Invasive Observational
Clinical Trial NCT07492511 (RECREANT) is an observational study for Trauma (Including Fractures), Trauma Patients, Kidney Disease, Hypovolemia, Hypervolemia, Kidney Failure that is recruiting. It started on 1 March 2026 with plans to enroll 350 participants. Led by Azienda Usl di Bologna, it is expected to complete by 30 June 2030. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
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 kidn...
Official Title
Renal and hEpatiC abnoRmal dopplEr pAtterns iN Trauma: a Multicentre Prospective Observational Study
Conditions
Trauma (Including Fractures)Trauma PatientsKidney DiseaseHypovolemiaHypervolemiaKidney FailureOther Study IDs
- RECREANT
- 665-2025-OSS-AUSLBO
NCT ID Number
Start Date (Actual)
2026-03-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2030-06-30
Enrollment (Estimated)
350
Study Type
Observational
Status
Recruiting
Keywords
VEXUS
trauma
kidney injury
kidney failure
Venous congestion
renal perfusion
Renal Doppler resistive index
major trauma
Hemodynamic phenotyping
ICU
trauma
kidney injury
kidney failure
Venous congestion
renal perfusion
Renal Doppler resistive index
major trauma
Hemodynamic phenotyping
ICU
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
N/A | Point 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. |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Age 18-65 years;
- Admission within 24h from traumatic injury;
- ISS >15
- 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
Azienda Usl di BolognaStudy Central Contact
Contact: Federico Moro, MD, 0039 0516478215, [email protected]
1 Study Locations in 1 Countries
Ospedale Maggiore C.A. Pizzardi AUSL Bologna, Bologna, Italy
Federico Moro, MD, Contact, 0039 0516478215, [email protected]
Lorenzo Gamberini, MD, Principal Investigator
Marco Tartaglione, MD, Sub-Investigator
Valentina Chiarini, MD, Sub-Investigator
Federico Moro, MD, Sub-Investigator
Recruiting