Trauma (Including Fractures)RECREANTNCT07492511
Renal and Hepatic Abnormal Doppler Patterns in Trauma
An observational study of Trauma (Including Fractures) and Trauma Patients, run by Azienda Usl di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma (Including Fractures), Trauma Patients, Kidney Disease
- What is being tested?
- Point of care ultrasound
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2026to 30 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age 18-65 years;
- Admission within 24h from traumatic injury;
- ISS >15
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Maggiore C.A. Pizzardi AUSL Bologna
Bologna
Federico Moro, MD, 0039 0516478215, federico.moro@ausl.bologna.it
Lorenzo Gamberini, MD
About this study
Official title: 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:
Read more
- 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
- Being tested
- Point of care ultrasound
- Keywords
- VEXUS, trauma, kidney injury, kidney failure, Venous congestion, renal perfusion, Renal Doppler resistive index, major trauma, Hemodynamic phenotyping, ICU
- Medical subject headings
- Wounds and Injuries, Kidney Diseases, Hypovolemia, Edema, Renal Insufficiency, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care ultrasoundDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At hospital discharge (assessed up to hospital discharge, expected within 90 days after ICU admission)
30-day ventilator-free days
Measured: 30-day after enrollment
Long-term renal function
(creatinine at 6 months ±2 weeks)
Measured: 6 months ±2 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma (Including Fractures)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Usl di Bologna
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492511
- Sponsor's protocol ID
- 665-2025-OSS-AUSLBO
- Acronym
- RECREANT
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal and hEpatiC abnoRmal dopplEr pAtterns iN Trauma: a Multicentre Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07492511
- Acronym / sponsor ID
- RECREANT / 665-2025-OSS-AUSLBO
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Azienda Usl di BolognaOther government
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18-65 years;
- Admission within 24h from traumatic injury;
- ISS >15
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care ultrasoundNon-invasive bedside ultrasound assessment (renal Doppler and VExUS score) performed at baseline (≤6h from ICU admission), 24h, 48h, and 72h. No intervention is administered. | Diagnostic test | – |
Primary outcome
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.
6 secondary outcomes
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
Acute kidney injury severity according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria
Time frame: From enrollment up to 7 days after ICU admission
Persistent acute kidney injury according to KDIGO criteria
Time frame: From 48 hours after AKI onset up to 7 days after ICU admission
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)
30-day ventilator-free days
Time frame: 30-day after enrollment
Long-term renal function
Time frame: 6 months ±2 weeks after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma (Including Fractures) and Trauma Patients, run by Azienda Usl di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Moro, MD (0039 0516478215, federico.moro@ausl.bologna.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.