Nephroprotection in Severe Trauma Patients With Kidney Stress (NephroTrauma)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Trauma; Complications

Treatments: Other: Standard-of-care; Other: Systematic nephroprotection bundle-of-care

Study type: Interventional

Funder types: Other

Identifiers

NCT06834633

69HCL21_1435

2022-A01052-41 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 523 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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523 participants in 3 patient groups

Observational group

Other group

Description:

Patients in the observational group will be managed according to the unit's standard-of-care, as in the control group, but without investigators knowing the patient's risk of AKI (NC score not known)

Treatment:

Other: Standard-of-care

Control group: Standard-of-care

Other group

Description:

Patients at risk of AKI (NC\>0.3) randomized in the control group will be managed according to the unit's standard-of-care.

Treatment:

Other: Standard-of-care

Intervention group: nephroprotection bundle-of-care

Experimental group

Description:

Patients at risk of AKI (NC\>0.3) randomized in the intervention group will receive the systematic and complete application of a nephroprotection bundle-of-care for three days following ICU admission.

Treatment:

Other: Systematic nephroprotection bundle-of-care