Nephroprotection in Severe Trauma Patients With Kidney Stress

Официальное название

Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое Standard-of-care
  Management according to current ICU practices
• Другое Systematic nephroprotection bundle-of-care
  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

Первичные конечные точки

• Proportion of patients developing an AKI episode within 3 days after ICU admission. [Срок оценки: During 3 days from ICU admission.]

Вторичные конечные точки (12)

• Proportion of patients with AKI within 7 days of ICU admission [Срок оценки: During 7 days from ICU admission]
• Proportion of patients with severe AKI within 3 days of ICU admission [Срок оценки: During 3 days from ICU admission]
• Proportion of patients with severe AKI within 7 days of ICU admission [Срок оценки: During 7 days from ICU admission]
• Proportion of patients with MAKE (MAjor Adverse Kidney Event) 28 [Срок оценки: 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 [Срок оценки: During 7 days after ICU admission.]
• Proportion of patients with at least one episode of dysglycemia within 3 days after ICU admission [Срок оценки: During 3 days after ICU admission.]
• ICU and hospital length-of-stay [Срок оценки: During 28 days from ICU admission]
• Identification of risk factors for AKI in trauma patients using clinical and laboratory parameters [Срок оценки: During 7 days from ICU admission]
• Incidence of AKI in trauma patients within 3 days of ICU admission based on KDIGO Criteria [Срок оценки: During 3 days after ICU admission]
• Characterization of AKI episodes phenotype in trauma patients using KDIGO criteria [Срок оценки: During 7 days from ICU admission]
• Proportion of patients receiving the nephroprotection bundle-of-care in its entirety, by component, and by practice. [Срок оценки: 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. [Срок оценки: At 7 days after ICU admission]

Критерии участия

Критерии включения

• Adult patient (≥ 18 years)
• Severe trauma patients (ISS score > 15) admitted to a trauma center
• Time between trauma and admission to trauma center <6h
• High risk of AKI: at least one NC score greater than 0.3 within 12 hours of admission to critical care (intensive care and continuous monitoring unit)
• 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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 6 центров

• Centre Hospitalier universitaire Estaing, Service anesthésie-réanimation — Clermont-Ferrand
• Centre hospitaler Annecy Genevois, Service de réanimation — Épagny
• Centre hospitalier universitaire de Grenoble Alpes, Pôle anesthésie-réanimation — La Tronche
• Hospices Civils de Lyon, Hôpital Edouard Herriot, Service d'anesthésie-réanimation — Lyon
• Hospices Civils de Lyon, Hôpital Lyon-Sud, Service d'anesthésie-réanimation — Pierre-Bénite
• Centre hospitalier universitaire de Saint Etienne, Hôpital Bellevue, Service anesthésie-ré — Saint-Etienne

Идентификаторы

NCT: NCT06834633 · 69HCL21_1435 · 2022-A01052-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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