Acute Respiratory Distress Syndrome (ARDS)
Conditions
Keywords
Acute Respiratory Distress Syndrome, ARDS, Corticosteroid
Brief summary
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.
Interventions
OTHERNo steroids (Arm A)
Standard care for ARDS without corticosteroids.
DRUGCorticosteroids, low dose for 10 days
Dexamethasone: low dose for 10 days
DRUGCorticosteroids, low dose for 7 days
Dexamethasone: low dose for 7 days
DRUGCorticosteroids, medium dose for 10 days
Dexamethasone: medium dose for 10 days
DRUGCorticosteroids, medium dose for 7 days
Dexamethasone: medium dose for 7 days
OTHERNo steroids (Arm B)
Standard care for ARDS without corticosteroids.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Uncontrolled infeciotn
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 28-day ventilator-free survival | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 28-day ventilator-free survival between low and medium dose groups | 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. |
| 28-day ventilator-free survival between long and short treatment duration groups | 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) |
| ICU mortality | From ICU admission to discharge, an average of 21 days | Proportion of death in the ICU |
| 60-day mortality | 60 days | Proportion of death in 60 days |
| Oxygenation improvement on day 7 | 7 days | Proportion of patients with PaO2/FiO2 ratio \> 200 mmHg on day 7 |
| Proportion of nosocomial infection | 30 days | Proportion of nosocomial infection during hospitalization (up to 30 days) |
| Proportion of lymphocytopenia | 10 days | Proportion of lymphocytopenia in 10 days |
| Hyperglycemia | 10 days | Peak blood glucose level during initial 10 days |
Countries
Taiwan
Contacts
CONTACTSheng-Yuan Ruan, MD, PhD
Outcome results
None listed