Clinical trial NCT06834633: Nephroprotection in Severe Trauma Patients With Kidney Stress
Official title: Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma; Complications
Keywords: Severe trauma
Acute Kidney Injury
Nephroprotection bundle-of-care
Biomarker
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 523
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be conducted in two phases:

Observational phase (4 months): describe the usual management practices and the incidence of AKI in each center.

Severe trauma patients (ISS \>15) will have a urine sample taken for NC measurement within 12 hours of admission to critical care. The NC value will not be disclosed to practitioners. Only patients with NC\>0.3 will be included retrospectively Interventional phase (20 months): aims to evaluate the effectiveness of a nephroprotection bundle-of-care (adaptation of the "KDIGO" protocol).

Patients with ISS\>15 will have a urine sample taken for NC measurement within 12 hours of admission to critical care. The NC result will be returned to the practitioner. If NC \> 0.3, the patient can be included and randomized. Randomization will be stratified by center. In the intervention group, the nephroprotection bundle-of-care will be applied for 3 days following admission to critical care. In the control group, patients will be managed as usual
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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
* Patient with indwelling urinary catheter
* High risk of AKI: measurement of NC score on fresh urine performed as soon as possible within 12 hours of admission to ICU and value \> 0.3.
* 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).

Primary outcomes:
measure: Proportion of patients developing an AKI episode within 3 days after ICU admission.
timeFrame: During 3 days from ICU admission.
Secondary outcomes:
measure: Proportion of patients with AKI within 7 days of ICU admission
timeFrame: During 7 days from ICU admission
measure: Proportion of patients with severe AKI within 3 days of ICU admission
timeFrame: During 3 days from ICU admission
measure: Proportion of patients with severe AKI within 7 days of ICU admission
timeFrame: During 7 days from ICU admission
measure: Proportion of patients with MAKE (MAjor Adverse Kidney Event) 28
timeFrame: At 28 days after ICU admission
measure: Proportion of patients with a complication among cardiovascular and hemodynamic complications; septic complications; hemorrhagic complications within 7 days after ICU admission
timeFrame: During 7 days after ICU admission.
measure: Proportion of patients with at least one episode of dysglycemia within 3 days after ICU admission
timeFrame: During 3 days after ICU admission.
measure: ICU and hospital length-of-stay
timeFrame: During 28 days from ICU admission
measure: Identification of risk factors for AKI in trauma patients using clinical and laboratory parameters
timeFrame: During 7 days from ICU admission
measure: Incidence of AKI in trauma patients within 3 days of ICU admission based on KDIGO Criteria
timeFrame: During 3 days after ICU admission
measure: Characterization of AKI episodes phenotype in trauma patients using KDIGO criteria
timeFrame: During 7 days from ICU admission
measure: Proportion of patients receiving the nephroprotection bundle-of-care in its entirety, by component, and by practice.
timeFrame: During 3 days after ICU admission
measure: Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 7 days after ICU admission.
timeFrame: At 7 days after ICU admission
measure: Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 28 days after ICU admission.
timeFrame: At 28 days after ICU admission
measure: Average costs of initial hospital stay for each group
timeFrame: During 28 days after ICU admission
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
city: La Tronche
country: France
facility: Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
city: Lyon
country: France
facility: Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
city: Pierre-Bénite
country: France
facility: Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
city: Saint-Étienne
country: France
facility: Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
city: Épagny
country: France
facility: Centre hospitaler Annecy Genevois, Service de réanimation
Study officials:
affiliation: Hospices Civils de Lyon
name: Céline MONARD
role: PRINCIPAL_INVESTIGATOR
References: