Nephroprotection in Severe Trauma Patients With Kidney Stress

Recruiting now · Not applicable

Conditions studied: Trauma; Complications

In brief

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 implemented in its totality, due to the significant financial and human resources required for its full implementation. The Nephrocheck® (NC) test is a urine test for which a result \> 0.3 is predictive of AKI development. It might enable early identification of trauma patients at risk of AKI, so that implementation of the nephroprotection bundle-of-care could be targeted solely at those high-risk patients. Thus, the investigators hypothesize that in a population of severe trauma patients (ISS score\>15) at risk of AKI (defined by a NC on Intensive Care Unit (ICU) admission \> 0.3), early implementation of a nephroprotection bundle-of-care would reduce the risk of AKI occurring within 3 days of ICU admission, compared with standard-of-care management. This study will compare the occurrence of AKI in these two groups in a multicenter randomized controlled trial.

Key facts

Study ID: NCT06834633
Run by: Hospices Civils de Lyon
People needed: 523
Starts: 2025-07-09
Expected to finish: 2027-09-01
Last updated by the study team: 2026-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

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

Full record on ClinicalTrials.gov

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