AKI Biomarkers in Coronavirus(COVID)-19

• Conditions: COVID; Acute Respiratory Failure; Acute Kidney Injury

• Registration Number: NCT04408248
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-27
• Study First Posted: 2020-05-29
• Study Start: 2020-08-20
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Moderate or severe respiratory disease as defined by Berlin criteria
2. COVID-19 positive
3. Age ≥ 18 years

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any stage of acute kidney injury	7 days	As defined by Kidney Diseases: Improving Global Outcome

Secondary Outcome Measures

Name	Time	Method
need for RRT in first 7 days	7 days	Renal replacement therapy requirement at the clinicians' discretion
Mortality	7 and 28 days	ICU mortality
Duration of mechanical ventilation	7 and 28 days	Duration
Duration of vasopressor support	7 and 28 days	Duration

Trial Locations

Locations (1)

Guy's & St Thomas' Hospital; 🇬🇧 London, United Kingdom