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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
523
Management according to current ICU practices
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
Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation
Clermont-Ferrand, France
RECRUITINGCentre hospitaler Annecy Genevois, Service de réanimation
Épagny, France
RECRUITINGCentre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation
La Tronche, France
RECRUITINGHospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation
Lyon, France
RECRUITINGHospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation
Pierre-Bénite, France
RECRUITINGCentre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation
Saint-Etienne, France
RECRUITINGProportion of patients developing an AKI episode within 3 days after ICU admission.
AKI will be defined according to KDIGO (Kidney Disease: Improving Global Outcomes) criteria, either by a drop in urine output (oliguria \< 0.5ml/kg/h for 6h) and/or a rise in serum creatinine (1.5x baseline or increase of 26.5 µmol/l).
Time frame: During 3 days from ICU admission.
Proportion of patients with AKI within 7 days of ICU admission
AKI will be defined according to KDIGO criteria, either by a drop in urine output (oliguria \< 0.5ml/kg/h for 6h) and/or a rise in serum creatinine (1.5x baseline or increase of 26.5 µmol/l).
Time frame: During 7 days from ICU admission
Proportion of patients with severe AKI within 3 days of ICU admission
Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria
Time frame: During 3 days from ICU admission
Proportion of patients with severe AKI within 7 days of ICU admission
Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria
Time frame: During 7 days from ICU admission
Proportion of patients with MAKE (MAjor Adverse Kidney Event) 28
MAKE 28 is defined by the occurrence of one event among (1) death before day 28 after ICU admission, (2) requirement of renal replacement therapy on day 28 or (3) incomplete renal recovery on day 28.
Time frame: At 28 days after ICU admission
Proportion of patients with a complication among cardiovascular and hemodynamic complications; septic complications; hemorrhagic complications within 7 days after ICU admission
Cardiovascular or hemodynamic complications include ventricular cardiac rhythm disorders, cardiogenic acute pulmonary edema and poorly controlled arterial hypertension \[MAP (Mean Arterial Pressure) \> 120 mmHg for 4 hours\]. Septic complications correspond to sepsis defined by the association of an infection and an increase in SOFA \>=2. Hemorrhagic complications are defined by the number of packed red blood cells (RBCs) used.
Time frame: During 7 days after ICU admission.
Proportion of patients with at least one episode of dysglycemia within 3 days after ICU admission
Episodes of dysglycemia are defined as hypoglycemia (\<4mmol/l) or hyperglycemia (\>12mmol/l).
Time frame: During 3 days after ICU admission.
ICU and hospital length-of-stay
Total number of days spent in critical care (intensive care, continuous care) and in the initial hospital
Time frame: During 28 days from ICU admission
Identification of risk factors for AKI in trauma patients using clinical and laboratory parameters
Known and novel risk factors for AKI in trauma patients will be evaluated using clinical variables (e.g., age, comorbidities, injury severity scores), hemodynamic parameters (e.g., MAP, lactate), and biomarkers of kidney function (e.g., CPK, TIMP-2/IGFBP-7)
Time frame: During 7 days from ICU admission
Incidence of AKI in trauma patients within 3 days of ICU admission based on KDIGO Criteria
The incidence of all stages and severe AKI in trauma patients at risk will be assessed based on the KDIGO criteria
Time frame: During 3 days after ICU admission
Characterization of AKI episodes phenotype in trauma patients using KDIGO criteria
Acute Kidney Injury episodes will be characterized based on a combination of factors including : * Time to AKI onset: defined as the time (in hours) from ICU admission to the diagnosis of AKI * Diagnostic criteria: whether the AKI is diagnosed based on serum creatinine or urine output changes * Severity: the highest KDIGO stage (1, 2, or 3) reached during the episode * Duration: transient (\<48h) or persistent (≥48h) AKI.
Time frame: During 7 days from ICU admission
Proportion of patients receiving the nephroprotection bundle-of-care in its entirety, by component, and by practice.
The entirety of the nephroprotection bundle-of-care is defined by the combination of at least one practice from each component: medication, hemodynamics, rhabdomyolysis, monitoring, glycemia
Time frame: During 3 days after ICU admission
Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 7 days after ICU admission.
The incremental cost-effectiveness ratio will be expressed as the additional cost per AKI avoided.
Time frame: At 7 days after ICU admission
Cost-effectiveness incremental ratio of the nephroprotection bundle-of-care compared with standard-of-care at 28 days after ICU admission.
The incremental cost-effectiveness ratio will be expressed as the additional cost per AKI avoided.
Time frame: At 28 days after ICU admission
Average costs of initial hospital stay for each group
Time frame: During 28 days after ICU admission
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