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RECRUITING
NCT06834633
NA

Nephroprotection in Severe Trauma Patients With Kidney Stress

Sponsor: Hospices Civils de Lyon

View on ClinicalTrials.gov

Summary

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.

Official title: Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

523

Start Date

2025-07-09

Completion Date

2027-09

Last Updated

2025-07-11

Healthy Volunteers

No

Interventions

OTHER

Standard-of-care

Management according to current ICU practices

OTHER

Systematic nephroprotection bundle-of-care

The nephroprotection bundle-of-care includes 5 components: 1. Prevention of drugs' nephrotoxicity 2. Hemodynamic optimization, for 24h 3. Blood glucose control and avoidance of hyperglycemia 4. Early detection of rhabdomyolysis 5. Monitoring of renal function

Locations (6)

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