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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A01052-41 | Other Identifier | ID-RCB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational group | Other | 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) |
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| Control group: Standard-of-care | Other | Patients at risk of AKI (NC>0.3) randomized in the control group will be managed according to the unit's standard-of-care. |
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| Intervention group: nephroprotection bundle-of-care | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard-of-care | Other | Management according to current ICU practices |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion 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). | During 3 days from ICU admission. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | During 7 days from ICU admission |
| Proportion of patients with severe AKI within 3 days of ICU admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Céline MONARD | Contact | 04 72 11 13 27 | +33 | celine.monard@chu-lyon.fr |
| Karine POYAU | Contact | 04 72 11 53 81 | +33 | karine.poyau@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Céline MONARD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation | Not yet recruiting | Clermont-Ferrand | 63100 | France |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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
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| Systematic nephroprotection bundle-of-care | Other | The nephroprotection bundle-of-care includes 5 components:
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Severe AKI is defined as AKI stage 2 or 3 according to KDIGO criteria |
| 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 | 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. | 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. | 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). | 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 | 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) | 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 | 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 :
| 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 | 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. | 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. | At 28 days after ICU admission |
| Average costs of initial hospital stay for each group | During 28 days after ICU admission |
| Centre hospitaler Annecy Genevois, Service de réanimation | Not yet recruiting | Épagny | 74370 | France |
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| Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation | Not yet recruiting | La Tronche | 38700 | France |
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| Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation | Recruiting | Lyon | 69003 | France |
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| Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation | Recruiting | Pierre-Bénite | 69310 | France |
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| Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-réanimation | Not yet recruiting | Saint-Etienne | 42000 | France |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |