AKI Biomarkers in Coronavirus(COVID)-19

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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COVID, Acute Respiratory Failure, Acute Kidney Injury

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or severe respiratory disease as defined by Berlin criteria COVID-19 positive Age ≥ 18 years Exclusion Criteria: 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 pregnancy breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 patients with acute respiratory disease<br>Adult patients with COVID-19 and moderate or severe respiratory disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any stage of acute kidney injury | As defined by Kidney Diseases: Improving Global Outcome | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| need for RRT in first 7 days | Renal replacement therapy requirement at the clinicians' discretion | 7 days | 
| Mortality | ICU mortality | 7 and 28 days | 
| Duration of mechanical ventilation | Duration | 7 and 28 days | 
| Duration of vasopressor support | Duration | 7 and 28 days |