Acute Kidney Injury in COVID-19 Patients Admitted to the ICU: a Multicenter Cohort Analysis in 9 Large Hospitals in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,286
- 试验地点
- 9
- 主要终点
- Acute Kidney Injury (AKI)
研究概览
简要总结
The aim of this study is to evaluate the rate and outcomes of COVID-19 associated acute kidney injury (AKI) and use of kidney replacement therapy (KRT) in critically ill COVID-19 patients in ICUs in several large hospitals in Flanders, the northern region of Belgium. We will also explore the associations between several baseline risk factors for AKI, therapeutic strategies and COVID-19 related clinical signs and the occurrence of AKI and use of KRT.
详细描述
The aim of this study is to evaluate the rate and outcomes of COVID-19 associated acute kidney injury (AKI) and use of kidney replacement therapy (KRT) in critically ill COVID-19 patients in ICUs in several large hospitals in Flanders, the northern region of Belgium. We will also explore the associations between several baseline risk factors for AKI, therapeutic strategies and COVID-19 related clinical signs and the occurrence of AKI and use of KRT.
This will be a cohort analysis of the rate of COVID-19 associated AKI and KRT during the period 1 February 2020 - 31 January 2021 in 6 large hospitals in Flanders Belgium and 3 Flemish University Hospitals. We will collect patients' baseline characteristics, specific treatment for COVID-19, other relevant therapies and severity of illness and ICU and hospital outcome data. AKI will be assessed during ICU stay up to 21 days of ICU stay, and will be defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) definition. In addition, we will assess occurrence of AKI stages, duration of AKI, duration of AKI integrated with severity stage of AKI into the area under the curve of AKI, occurrence of rapid reversal of AKI, occurrence of Acute Kidney Disease (AKD) defined according to KDIGO.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Severe Acute Respiratory Syndrome CoronaVirus-2 (SARS-CoV-2) infection confirmed by Polymerase Chain Reaction (PCR) on nasopharyngeal swab or oropharyngeal swab or rectal swab or bronchoalveolar aspirate
- •admission to the ICU for monitoring or organ support
排除标准
- •asymptomatic COVID-19 patients admitted to the ICU for medical reason not related to COVID-19
结局指标
主要结局
Acute Kidney Injury (AKI)
时间窗: up to day 21 of ICU admission
AKI occurrence and severity stages defined according to KDIGO
Kidney outcome
时间窗: day 30 after ICU admission
use of KRT and eGFR in patients without AKI (no AKI), AKI, and AKI stages
Mortality
时间窗: day 30 after ICU admission
Mortality of AKI and no AKI patients will be compared
Survival
时间窗: AKI and AKD will be classified up to day 21 of ICU stay, and survival will be assessed up to day 30 or hospital discharge whichever is last
Survival of no AKI, AKI and AKI stages, AKD, and rapid reversal up to day 30 or hospital discharge whichever comes last
次要结局
- Acute Kidney Injury (AKI), rapid reversal(up to day 21 of ICU admission)
- Survival AKI-AUC(AKI-AUC will be assessed up to day 21 of ICU stay, and survival will be assessed up to day 30 or hospital discharge whichever is last)
- Acute Kidney Injury (AKI) urine output criteria(up to day 21 of ICU admission)
- Mortality AKD(day 30 after ICU admission)
- Mortality AKI stage 2-3(day 30 after ICU admission)
- Mortality AKI creatinine criteria versus urine output criteria versus full KDIGO(day 30 after ICU admission)
- Mortality AKI-AUC(day 30 after ICU admission)
- Subgroup analysis: obese (BMI>30 kg/m2)(ICU admission up to day 21)
- Acute Kidney Injury (AKI) creatinine criteria(up to day 21 of ICU admission)
- Acute Kidney Disease (AKD)(up to day 21 of ICU admission)
- AKI-Area Under the Curve (AUC)(up to day 21 of ICU admission)
- Duration of AKI and AKD(up to day 21 of ICU admission)
- KRT modality(ICU admission up to day 21)
- Subgroup analysis: Chronic Kidney Disease (CKD) (estimated glomerular filtration rate (eGFR)<60 mL/min)(ICU admission up to day 21)
- Subgroup analysis: prone ventilation(ICU admission up to day 21)
- Subgroup analysis: extracorporeal membrane oxygenation (ECMO)(ICU admission up to day 21)
- Mortality AKI rapid reversal(day 30 after ICU admission)
- Mortality AKI treated with KRT(day 30 after ICU admission)
- Recovery of AKI and AKD(day 30 after ICU admission)
- Timing of AKI, AKI severity grades and use of KRT(ICU admission up to day 21)
- Subgroup analysis: Mechanical Ventilation(ICU admission up to day 21)
- Subgroup analysis: elderly (>= 65 y)(ICU admission up to day 21)
- Kidney outcome AKI KDIGO creatinine or urine output(day 30 after ICU admission)
- use of KRT(ICU admission up to day 21)