National Taiwan University Hospital
Taipei, 10002, Taiwan
Location status: Recruiting
NCT Number: NCT07711964
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Taipei, 10002, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 28 days
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
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
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: From ICU admission to discharge, an average of 21 days
Proportion of death in the ICU
Time frame: 60 days
Proportion of death in 60 days
Time frame: 7 days
Proportion of patients with PaO2/FiO2 ratio > 200 mmHg on day 7
Time frame: 30 days
Proportion of nosocomial infection during hospitalization (up to 30 days)
Time frame: 10 days
Proportion of lymphocytopenia in 10 days
Time frame: 10 days
Peak blood glucose level during initial 10 days
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
Corticosteroids for Acute Respiratory Distress Syndrome: A Proof-of-Concept Trial Exploring Biological Heterogeneity and Treatment Response
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