Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07711964

Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location status: Recruiting

Location contact

Research Ethics Committee of NTUH

CONTACT

[email protected]

886233667190

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No steroids (Arm A)

Other

Standard care for ARDS without corticosteroids.

Corticosteroids, low dose for 10 days

Drug

Dexamethasone: low dose for 10 days

Corticosteroids, low dose for 7 days

Drug

Dexamethasone: low dose for 7 days

Corticosteroids, medium dose for 10 days

Drug

Dexamethasone: medium dose for 10 days

Corticosteroids, medium dose for 7 days

Drug

Dexamethasone: medium dose for 7 days

No steroids (Arm B)

Other

Standard care for ARDS without corticosteroids.

Primary outcomes

  1. 28-day ventilator-free survival

    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)

Secondary outcomes

  1. 28-day ventilator-free survival between low and medium dose groups

    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.

  2. 28-day ventilator-free survival between long and short treatment duration groups

    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)

  3. ICU mortality

    Time frame: From ICU admission to discharge, an average of 21 days

    Proportion of death in the ICU

  4. 60-day mortality

    Time frame: 60 days

    Proportion of death in 60 days

  5. Oxygenation improvement on day 7

    Time frame: 7 days

    Proportion of patients with PaO2/FiO2 ratio > 200 mmHg on day 7

  6. Proportion of nosocomial infection

    Time frame: 30 days

    Proportion of nosocomial infection during hospitalization (up to 30 days)

  7. Proportion of lymphocytopenia

    Time frame: 10 days

    Proportion of lymphocytopenia in 10 days

  8. Hyperglycemia

    Time frame: 10 days

    Peak blood glucose level during initial 10 days

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng-Yuan Ruan, MD, PhD

CONTACT

[email protected]

886223123456

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jul 17, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.