Efficacy of DEXamethasone in Patients With Acute Hypoxemic REspiratory Failure Caused by INfEctions
Status:
Not yet recruiting
Trial end date:
2023-12-30
Target enrollment:
Participant gender:
Summary
Background: There are no proven therapies specific for pulmonary dysfunction in patients with
acute hypoxemic respiratory failure (AHRF) caused by infections (including Covid-19). The
full spectrum of AHRF ranges from mild respiratory tract illness to severe pneumonia, acute
respiratory distress syndrome (ARDS), multiorgan failure, and death. The efficacy of
corticosteroids in AHRF and ARDS caused by infections remains controversial.
Methods: This is a multicenter, randomized, controlled, open-label clinical trial testing
dexamethasone in mechanically ventilated adult patients with established AHRF (including
ARDS) caused by confirmed pulmonary or systemic infections, admitted in a network of Spanish
ICUs. Eligible patients will be randomly assigned to receive dexamethasone: either 6 mg/d x
10 days or 20 mg/d x 5 days followed by 10 mg/d x 5 days. The primary outcome is 60-day
mortality. The secondary outcome is the number of ventilator-free days at 28 days. All
analyses will be done according to the intention-to-treat principle.