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Nephroprotection in Severe Trauma Patients With Kidney Stress

RecruitingNAAges 18 Years - anyAllHospices Civils de Lyon
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In plain words

What the trial is, and whether it could suit you

Acute Kidney Injury (AKI) occurs in 24% of trauma patients, and is even more common in those with severe trauma. It is a major contributor to morbidity and mortality in trauma. Diagnosis of AKI is based on elevated serum creatinine and decreased urine output, two functional markers already indicating the presence of a significant kidney function impairment. Earlier detection of kidney stress, at a preclinical stage when cellular modifications are still reversible, could reduce the occurrence of AKI episodes if nephroprotective measures are rapidly implemented. Several randomized controlled trials have shown that early implementation of such a nephroprotection bundle-of-care in patients at risk of AKI after major surgery reduces the incidence of severe AKI within 72 hours. Although its use is supported by international guidelines, this nephroprotection bundle-of-care is rarely implemente

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📋 Eligibility rules (as published)
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).
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What it tests

  • Standard-of-care
  • Systematic nephroprotection bundle-of-care
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Where

6 sites
Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
Clermont-Ferrand, France
Centre hospitaler Annecy Genevois, Service de réanimation
Épagny, France
Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
La Tronche, France
Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
Lyon, France
Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
Pierre-Bénite, France
Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
Saint-Etienne, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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