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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Standard care for ARDS without corticosteroids.
Dexamethasone: low dose for 10 days
Dexamethasone: low dose for 7 days
Dexamethasone: medium dose for 10 days
Dexamethasone: medium dose for 7 days
Standard care for ARDS without corticosteroids.
National Taiwan University Hospital
Taipei, Taiwan
RECRUITING28-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)
Time frame: 28 days
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.
Time frame: 28 days
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)
Time frame: 28 days
ICU mortality
Proportion of death in the ICU
Time frame: From ICU admission to discharge, an average of 21 days
60-day mortality
Proportion of death in 60 days
Time frame: 60 days
Oxygenation improvement on day 7
Proportion of patients with PaO2/FiO2 ratio \> 200 mmHg on day 7
Time frame: 7 days
Proportion of nosocomial infection
Proportion of nosocomial infection during hospitalization (up to 30 days)
Time frame: 30 days
Proportion of lymphocytopenia
Proportion of lymphocytopenia in 10 days
Time frame: 10 days
Hyperglycemia
Peak blood glucose level during initial 10 days
Time frame: 10 days
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