About this trial
The early phase of Acute Respiratory Distress Syndrome (ARDS) is characterized by intense alveolar inflammation. Corticosteroids have been used to treat ARDS for decades. Although their efficacy has been a subject of ongoing controversy, recent clinical practice guidelines for ARDS issued a weak recommendation in favor of corticosteroid use in early ARDS. However, the optimal dose and duration of corticosteroid therapy remain unclear. Low-dose, short-course regimens have been evaluated in clinical trials for severe pneumonia and COVID-19. However, no head-to-head comparisons have been conducted to evaluate the efficacy of prolonged versus short courses of corticosteroid therapy in ARDS.
To address this gap, the investigators designed a 3×2 factorial trial to assess corticosteroid therapy for ARDS, aiming to evaluate the effects of different doses (no steroid, medium-low dose, and medium dose) and durations (prolonged vs. short) on clinical outcomes. In addition, the investigators will measure changes in inflammatory biomarkers for post hoc analysis to explore whether these biomarkers could guide the selection of steroid regimens.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ARDS (as defined by the Berlin definition) with an FiO₂ of 0.5 or higher
On invasive mechanical ventilation
Duration of intubation less than three days
Disqualifiers
Age less than 18 years
Required to receive steroids or considered ineligible for steroids by the primary care team
Receiving systemic steroid therapy
Uncontrolled gastrointestinal bleeding
Trial design
Factorial
Treatments tested in this trial
No steroids (Arm A)
Other interventionStandard care for ARDS without corticosteroids.
Corticosteroids, low dose for 10 days
DrugDexamethasone: low dose for 10 days
Corticosteroids, low dose for 7 days
DrugDexamethasone: low dose for 7 days
Corticosteroids, medium dose for 10 days
DrugDexamethasone: medium dose for 10 days
Corticosteroids, medium dose for 7 days
DrugDexamethasone: medium dose for 7 days
No steroids (Arm B)
Other interventionStandard care for ARDS without corticosteroids.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
28-day ventilator-free survival
Proportion of ventilator-free survival at day 28 between intervention arms (arms C, D, E, and F) and control arms (arms A and B)
Secondary outcomes
28-day ventilator-free survival between low and medium dose groups
Proportion of ventilator-free survival at day 28 between low dose (arm C and D) and medium dose (arm E and F) of corticosteroids.
28-day ventilator-free survival between long and short treatment duration groups
Proportion of ventilator-free survival at day 28 between long-course treatment (arms C and E) and short-course treatment (arms D and F)
ICU mortality
Proportion of death in the ICU
60-day mortality
Proportion of death in 60 days
Sponsors and contacts
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