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Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome

RecruitingPhase 4Ages 18 Years - anyAllNational Taiwan University Hospital
NCT07711964 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • No steroids (Arm A)
  • Corticosteroids, low dose for 10 days
  • Corticosteroids, low dose for 7 days
  • Corticosteroids, medium dose for 10 days
  • Corticosteroids, medium dose for 7 days
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Where

1 site
National Taiwan University Hospital
Taipei, Taiwan
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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