AKI Biomarkers in Coronavirus(COVID)-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 patients with acute respiratory disease Adult patients with COVID-19 and moderate or severe respiratory disease |
Outcome Measures
Primary Outcome Measures
- Any stage of acute kidney injury [7 days]
As defined by Kidney Diseases: Improving Global Outcome
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Guy's & St Thomas' Hospital | London | United Kingdom | SE1 7EH |
Sponsors and Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- University Hospital Muenster
Investigators
- Principal Investigator: Marlies Ostermann, MD, PhD, Guy's and St Thomas' NHS Foundation Trust
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 283675