Grant: Operating Grant: Clinical Trials Projects - Indirect Costs

Acute hypoxemic respiratory failure (AHRF), or acute breathing problems, are one of the most common reasons to require hospital admission, or in the most severe cases, admission to the intensive care unit (ICU) for advanced oxygen support. AHRF has multiple causes including pneumonia (COVID or bacterial), aspiration, or even illness in other organs of the body (such as sepsis or pancreatitis) which lead to lung inflammation. Corticosteroids, a group of immune suppressing drugs, have been investigated as a potential therapy for AHRF. Smaller studies have shown benefit of corticosteroids in hospitalized patients with severe pneumonia and in those with a form of severe ARF called ARDS (acute respiratory distress syndrome). Despite this, clinical practice remains varied. Dexamethasone, a type of corticosteroid, was one of the first therapies to show benefit in hospitalized patients with COVID-19 and has now become the standard of therapy in this population. Whether this is also helpful for other causes of ARF remains unclear. Another really important question is how long to treat with corticosteroids in patients with ARF. The largest of the COVID studies used a short course of 10 days, but uncertainty remains, especially if a patient is not improving after 10 days of treatment. We propose to answer two questions within the same research platform. The platform (called PRACTICAL) aims to study many different interventions for treating ICU patients with AHRF. Within this platform, we propose to study corticosteroids: 1) in patients with non-COVID AHRF requiring advanced oxygen support, 2) in patients with AHRF from COVID or non-COVID who have already been treated with a short course of corticosteroids and are still requiring advanced oxygen support, examining the role of extending the duration corticosteroids. The main outcome to be studied will be mortality at 60 days but we will also study a number of other outcomes that are important to patients.