Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT06834633
Eligibility Criteria:
Inclusion Criteria:
* Adult patient (≥ 18 years)
* Severe trauma patients (ISS score \> 15) admitted to a trauma center
* Time between trauma and admission to trauma center \<6h
* Patient with indwelling urinary catheter
* High risk of AKI: measurement of NC score on fresh urine performed as soon as possible within 12 hours of admission to ICU and value \> 0.3.
* Affiliated with a social security scheme or beneficiary of a similar scheme
* Consent signed by patient or close relative, or attestation signed by investigator in case of emergency
Exclusion Criteria:
* Adult under legal protection (guardianship, curators)
* Persons deprived of their liberty by judicial or administrative decision
* Patients taking part in other interventional research which may interfere with the research and which includes an exclusion period still in progress at the time of inclusion.
* Pregnant or breast-feeding woman (diagnosis of pregnancy by plasma βHCG (Beta-Human Chorionic Gonadotropin) assay routinely performed as part of the blood test on admission to the outpatient department of a woman of childbearing age).
* Patients with end-stage or severe chronic renal failure with Glomerular Filtration Rate (GFR) \< 30 milliliters/min/1.73m2 or chronic dialysis.
* Anuric patients
* Severe heart failure defined as Left Ventricular Ejection Fraction (LVEF) \<25%.
* Patient moribund on admission with an estimated length of stay of less than 24 hours
* Patient with AKI at time of randomization (developed prior to ICU admission or within the first 12 hours of ICU admission, before randomization).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06834633
Study Brief:
Protocol Section:
NCT06834633