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Recruiting NCT07711964

Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome

Phase IV Interventional Acute Respiratory Distress Syndrome (ARDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No steroids (Arm A), Corticosteroids, low dose for 10 days, Corticosteroids, low dose for 7 days, Corticosteroids, medium dose for 10 days.
Who it may be relevant to
Registry conditions: Acute Respiratory Distress Syndrome (ARDS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Corticosteroids for Acute Respiratory Distress Syndrome: A Proof-of-Concept Trial Exploring Biological Heterogeneity and Treatment Response

Overview

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

  • Other No steroids (Arm A)
    Standard care for ARDS without corticosteroids.
  • Drug Corticosteroids, low dose for 10 days
    Dexamethasone: low dose for 10 days
  • Drug Corticosteroids, low dose for 7 days
    Dexamethasone: low dose for 7 days
  • Drug Corticosteroids, medium dose for 10 days
    Dexamethasone: medium dose for 10 days
  • Drug Corticosteroids, medium dose for 7 days
    Dexamethasone: medium dose for 7 days
  • Other No steroids (Arm B)
    Standard care for ARDS without corticosteroids.

Primary outcome measures

  • 28-day ventilator-free survival [Time frame: 28 days]
Secondary outcome measures (8)
  • 28-day ventilator-free survival between low and medium dose groups [Time frame: 28 days]
  • 28-day ventilator-free survival between long and short treatment duration groups [Time frame: 28 days]
  • ICU mortality [Time frame: From ICU admission to discharge, an average of 21 days]
  • 60-day mortality [Time frame: 60 days]
  • Oxygenation improvement on day 7 [Time frame: 7 days]
  • Proportion of nosocomial infection [Time frame: 30 days]
  • Proportion of lymphocytopenia [Time frame: 10 days]
  • Hyperglycemia [Time frame: 10 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Taipei

Identifiers

NCT: NCT07711964 · 202503094MIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗