Acute respiratory distress syndrome (ARDS) is a clinical syndrome of inflammatory lung injury characterized by increased pulmonary vascular permeability, loss of aerated lung tissue, severe hypoxemia and impaired compliance. Despite the advance in the critical care technology, the mortality of ARDS remains high in the last decades. Glucocorticoids have profound anti-inflammatory actions through the pleiotropic effects of the glucocorticoid receptor, which are considering a promising pharmacological therapy to mitigate the inflammatory lung injury and subsequent fibrosis in ARDS. Previous clinical trials have repeatedly tested the efficacy of glucocorticoid therapy in ARDS; however, the data about hard outcomes, such as mortality, are inconsistent between these studies. Investigators designed a 3x2 factorial trial of glucocorticoid therapy in ARDS to test the effects of glucocorticoid dosages (dose 0, dose 0.5 mg/kg, and dose 1 mg/kg of methylprednisolone equivalence) and durations (prolonged and short duration) on the treatment efficacy. In addition, investigators will measure the change of inflammatory biomarkers for post-hoc analysis to explore whether biomarkers could be used to guide patient selection and steroid tapering.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Betamethasone, dexamethasone, or methylprednisolone
Ventilator-free survival
Ventilator-free survival between control and intervention arms
Time frame: 28 days
Glucocorticoid dose and ventilator-free survival
Ventilator-free survival between low-dose and moderate-dose glucocorticoid groups
Time frame: 28 days
Glucocorticoid treatment duration and ventilator-free survival
Ventilator-free survival between long treatment duration and short treatment duration groups
Time frame: 28 days
ICU mortality
Between-group difference in mortality at ICU discharge
Time frame: Length of ICU stay up to 28 days
Hospital mortality
Between-group difference in mortality at hospital discharge
Time frame: Length of hospital stay up to 60 days
60-day mortality
Between-group difference in mortality by day 60
Time frame: 60 days
Oxygenation on day 7
Proportion of patients with a P/F ratio \> 200 mmHg on day 7
Time frame: 7 days
Rapid oxygenation improvement
Change in P/F ratios between day 1 and day 3
Time frame: 3 days
Successful liberation from mechanical ventilation
Median time to successful liberation from mechanical ventilation
Time frame: Up to 60 days
Lymphocytopenia
Proportion of lymphocytopenia on day 7
Time frame: 7 days
Blood glucose level
Peak blood glucose level during treatment
Time frame: 10 days
Hyperglycemia
Proportion of patients with hyperglycemia during treatment
Time frame: 10 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.