Nephroprotection for severe trauma patients with early urine signs of kidney stress

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study enrolls adults with severe trauma (ISS >15) admitted within 6 hours who have an elevated urine NC score (>0.3) measured within 12 hours of ICU admission. Eligible patients are assigned to receive either standard care or a systematic nephrotection bundle-of-care initiated promptly after the biomarker result. The bundle follows guideline-recommended steps such as hemodynamic optimization, avoidance of nephrotoxins, and close urine/output and creatinine monitoring, applied early to try to stop reversible cellular kidney stress. Outcomes focus on preventing progression to acute kidney injury in the early post-trauma period and during the hospital stay.

Why it matters

Who can join: the full rules

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
* High risk of AKI: at least one NC score greater than 0.3 within 12 hours of admission to critical care (intensive care and continuous monitoring unit)
* 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).

Where it's running

• Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
  Clermont-Ferrand, France Recruiting
• Centre hospitaler Annecy Genevois, Service de réanimation
  Épagny, France Recruiting
• Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
  La Tronche, France Recruiting
• Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
  Lyon, France Recruiting
• Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
  Pierre-Bénite, France Recruiting
• Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
  Saint-Etienne, France Recruiting

Study contacts

• Principal investigator: Céline MONARD — Hospices Civils de Lyon
• Study coordinator: Céline MONARD
• Email: celine.monard@chu-lyon.fr
• Phone: 04 72 11 13 27

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.