Renal and Hepatic Abnormal Doppler Patterns in Trauma (RECREANT)

March 19, 2026 updated by: Azienda Usl di Bologna

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Bologna, Italy
        • Recruiting
        • Ospedale Maggiore C.A. Pizzardi AUSL Bologna
        • Sub-Investigator:
          • Marco Tartaglione, MD
        • Contact:
        • Principal Investigator:
          • Lorenzo Gamberini, MD
        • Sub-Investigator:
          • Valentina Chiarini, MD
        • Sub-Investigator:
          • Federico Moro, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
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.
At baseline (within 6 hours of ICU admission), and at 24, 48, and 72 hours after ICU admission

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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
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.
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)
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
Time Frame: 30-day after enrollment
30-day after enrollment
Long-term renal function
Time Frame: 6 months ±2 weeks after hospital discharge
(creatinine at 6 months ±2 weeks)
6 months ±2 weeks after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Azienda Usl di Bologna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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