Actively Recruiting
Nephroprotection in Severe Trauma Patients With Kidney Stress
Led by Hospices Civils de Lyon · Updated on 2025-07-11
523
Participants Needed
6
Research Sites
112 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nephroprotection in Severe Trauma Patients With Kidney Stress
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient (18 years or older)
- Severe trauma with Injury Severity Score (ISS) above 15 admitted to a trauma center
- Time between trauma and trauma center admission less than 6 hours
- Presence of an indwelling urinary catheter
- High risk of AKI defined by a Nephrocheck score above 0.3 within 12 hours of ICU admission
- Affiliated with a social security or similar scheme
- Signed consent by patient, close relative, or investigator in emergencies
You will not qualify if you...
- Adult under legal protection (guardianship or curatorship)
- Persons deprived of liberty by judicial or administrative decision
- Participation in other interventional research with ongoing exclusion period
- Pregnant or breastfeeding women
- End-stage or severe chronic kidney failure with GFR less than 30 ml/min/1.73m2 or on chronic dialysis
- Anuric patients
- Severe heart failure with left ventricular ejection fraction below 25%
- Moribund patients on admission expected to stay less than 24 hours
- Patients with AKI prior to or within 12 hours of ICU admission before randomization
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
Clermont-Ferrand, France, 63100
Not Yet Recruiting
2
Centre hospitaler Annecy Genevois, Service de réanimation
Épagny, France, 74370
Not Yet Recruiting
3
Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
La Tronche, France, 38700
Not Yet Recruiting
4
Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
Lyon, France, 69003
Actively Recruiting
5
Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
Pierre-Bénite, France, 69310
Actively Recruiting
6
Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
Saint-Etienne, France, 42000
Not Yet Recruiting
Research Team
C
Céline MONARD
CONTACT
K
Karine POYAU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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