Prediction of Acute Kidney Injury in Patients With COVID-19 Associated Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 13
- 主要终点
- Occurence of acute kidney injury (AKI)
研究概览
简要总结
The two biomarkers determined in urine, "Tissue Inhibitor of Metalloproteinases 2 (TIMP-2)" and "Insulin-like Growth Factor-Binding Protein 7 (IGFBP7)", can indicate the occurrence of Acute kidney injury (AKI) in cardiac surgery and critically ill patients at an early stage. However, no data are available whether these parameters can also predict the occurrence of AKI in the context of COVID-19 infection. An early prediction of AKI can be helpful for the optimisation of therapeutic management to improve patient outcome and for the triage of patients.
The aim of this observational study is to evaluate whether the biomarker [TIMP- 2]*[IGFBP7] can predict the occurrence of AKI in critically ill patients suffering from SARS-CoV2 associated acute respiratory distress syndrome.
详细描述
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is rapidly spreading around the world. The current outbreak of infections with SARS-CoV-2 is termed Coronavirus Disease 2019 (COVID-19). Two other coronavirus infections, SARS in 2002-2003 and Middle East Respiratory Syndrome (MERS) in 2012, both caused severe respiratory syndrome in humans. All 3 of these emerging infectious diseases are caused by β-coronaviruses.
Although COVID-19 primarily affects the lungs and may cause severe hypoxemia, other organs including the GI tract, heart and kidney are affected. Acute kidney injury secondary to COVID-19 (COV-AKI) is reported to occur in about 15-25% of patients hospitalized with COVID-19 infection. The majority of AKI cases are mild to moderate with renal replacement requirement in about 25%. However, AKI was much more common in non-survivors (>50%). Although kidney failure appears to occur late in the course, patients may begin to develop AKI within the first 3 days of hospitalization. Similar to AKI in other settings,3 COV-AKI is likely to be of variable etiology. Thus, there may be a long window for treatment.
The two cell-cycle arrest markers, tissue inhibitor of metalloproteinases-2 (TIMP-2) and insulin-like growth-factor binding protein 7 (IGFBP7), have been shown to early predict the occurrence of AKI in cardiac surgical and critically ill patients. However, there is no data available whether (TIMP-2)*(IGFBP7) can predict the occurrence of AKI in the COVID19 setting. Early prediction of AKI may be valuable to optimize therapeutic management in order to improve patient's outcome and might be helpful to triage patients.
The goal of this observational trial is to evaluate whether (TIMP-2)*(IGFBP7) early predicts the occurrence of AKI in critically ill patients with SARS-CoV2 associated ARDS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Moderate or severe ARDS according to the Berlin definition
- •SARS-CoV2 positive test
- •Age ≥ 18 years
- •Informed consent
排除标准
- •Pre-existing AKI
- •Severe CKD with eGFR<20ml/min
- •Chronic dialysis dependency
- •Kidney transplant within the last 12 months
- •Pregnancy, breastfeeding
- •Persons with any kind of dependency on the investigator or employed by the sponsor or investigator.
结局指标
主要结局
Occurence of acute kidney injury (AKI)
时间窗: within 7 days after beginning of moderate or severe ARDS
Occurence of moderate or severe AKI
次要结局
- Mortality(up to 4 weeks after beginning of moderate or severe ARDS)
- Occurence of transient and persistent AKI(within 7 days after beginning of moderate or severe ARDS)
- Duration of renal replacement therapy(up to 4 weeks after beginning of moderate or severe ARDS)
- Duration of vasopressor administration(up to 4 weeks after beginning of moderate or severe ARDS)
- Duration of mechanical ventilation(up to 4 weeks after beginning of moderate or severe ARDS)
- Occurence of Renal replacement therapy during hospital stay(up to 4 weeks after beginning of moderate or severe ARDS)
- ICU length of stay(up to 4 weeks after beginning of moderate or severe ARDS)
- Hospital length of stay(up to 4 weeks after beginning of moderate or severe ARDS)