Impact of a Nephroprotection Bundle-of-care in Severe Trauma Patients at Risk of Acute Kidney Injury: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 523
- 试验地点
- 16
- 主要终点
- Proportion of patients developing an AKI episode within 3 days after ICU admission.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
Observational group
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)
干预措施: Standard-of-care (Other)
Control group: Standard-of-care
Patients at risk of AKI (NC>0.3) randomized in the control group will be managed according to the unit's standard-of-care.
干预措施: Standard-of-care (Other)
Intervention group: nephroprotection bundle-of-care
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.
干预措施: Systematic nephroprotection bundle-of-care (Other)
结局指标
主要结局
Proportion of patients developing an AKI episode within 3 days after ICU admission.
时间窗: During 3 days from 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).
次要结局
- Proportion of patients with AKI within 7 days of ICU admission(During 7 days from ICU admission)
- Proportion of patients with severe AKI within 3 days of ICU admission(During 3 days from ICU admission)
- Proportion of patients with severe AKI within 7 days of ICU admission(During 7 days from ICU admission)
- Proportion of patients with MAKE (MAjor Adverse Kidney Event) 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(During 7 days after ICU admission.)
- Proportion of patients with at least one episode of dysglycemia within 3 days after ICU admission(During 3 days after ICU admission.)
- ICU and hospital length-of-stay(During 28 days from ICU admission)
- Identification of risk factors for AKI in trauma patients using clinical and laboratory parameters(During 7 days from ICU admission)
- Incidence of AKI in trauma patients within 3 days of ICU admission based on KDIGO Criteria(During 3 days after ICU admission)
- Characterization of AKI episodes phenotype in trauma patients using KDIGO criteria(During 7 days from ICU admission)
- Proportion of patients receiving the nephroprotection bundle-of-care in its entirety, by component, and by practice.(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.(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.(At 28 days after ICU admission)
- Average costs of initial hospital stay for each group(During 28 days after ICU admission)