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临床试验/NCT04408248
NCT04408248Unknown不适用

AKI Biomarkers for Prediction of Acute Kidney Injury in Critically Ill Patients With COVID-19 and Respiratory Disease

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年8月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Any stage of acute kidney injury

研究概览

简要总结

This research aims to investigate the role of daily measurement of urinary cell cycle arrest markers and other serum and urinary biomarkers to predict the development of acute kidney injury in critically ill patients with COVID-19 and acute respiratory disease.

详细描述

COVID-19 is a rapidly evolving pandemic with approximately 5% of all patients requiring admission to an intensive care unit. In critically ill patients with COVID-19, acute respiratory disease and acute kidney injury (AKI) are very common. Patients with AKI have an increased risk of mortality, especially renal replacement therapy (RRT) is required. The latest Intensive Care National Audit & Research Centre (ICNARC) report shows a 77% ICU mortality in patients with COVID-19 who require mechanical ventilation and RRT.

COVID-19 associated AKI is still poorly understood. The exact underlying pathophysiology remains unknown. Furthermore, there are no specific strategies to prevent or treat AKI. Management is supportive consisting of fluid and haemodynamic optimization, discontinuation of nephrotoxic drugs and prevention of nephrotoxic exposures. Ideally, AKI needs to be recognized as early as possible for these supportive measures to be effective.

Early prediction of AKI may be valuable to optimize management and improve outcomes. In critically ill patients without COVID-19, 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 predict the development of AKI. Whether these new biomarkers also predict the development of AKI in critically ill patients with COVID-19 is unknown.

The aim of this project is to explore whether urinary cell cycle arrest markers and other renal biomarkers have a role in predicting AKI in critically ill patients with COVID-19 and acute respiratory disease. The results will advance the understanding of this disease and serve to develop strategies for individualized management of this high-risk group.

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

入选标准

  • Moderate or severe respiratory disease as defined by Berlin criteria
  • COVID-19 positive
  • Age ≥ 18 years

排除标准

  • pre-existing AKI
  • severe chronic kidney disease (CKD) with estimated glomerular filtration rate (eGFR) <20ml/min
  • end-stage renal failure on regular dialysis
  • kidney transplant within the last 12 months
  • breastfeeding

结局指标

主要结局

Any stage of acute kidney injury

时间窗: 7 days

As defined by Kidney Diseases: Improving Global Outcome

次要结局

  • Duration of mechanical ventilation(7 and 28 days)
  • Duration of vasopressor support(7 and 28 days)
  • need for RRT in first 7 days(7 days)
  • Mortality(7 and 28 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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