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Recruiting NCT07492511

Renal and Hepatic Abnormal Doppler Patterns in Trauma

— Observational Trauma (Including Fractures) Trauma Patients Kidney Disease Hypovolemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Point of care ultrasound.
Who it may be relevant to
Registry conditions: Trauma (Including Fractures), Trauma Patients, Kidney Disease, Hypovolemia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test 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

  • 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]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Ospedale Maggiore C.A. Pizzardi AUSL Bologna — Bologna

Identifiers

NCT: NCT07492511 · 665-2025-OSS-AUSLBO

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗