Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome

NCT07711964 | Recruiting Phase 4

• 1 other identifier: 202503094MIND
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

Acute Respiratory Distress Syndrome; ARDS; Corticosteroid

Outcome Measures

Primary Outcomes (1)

• 28-day ventilator-free survival

  Proportion of ventilator-free survival at day 28 between intervention arms (arms C, D, E, and F) and control arms (arms A and B)

  28 days

Secondary Outcomes (8)

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

  28 days

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

  28 days

• ICU mortality

  From ICU admission to discharge, an average of 21 days

• 60-day mortality

  60 days

• Oxygenation improvement on day 7

  7 days

Study Arms (6)

(Arm A) No steroids

OTHER

Standard care without corticosteroid therapy.

Other: No steroids (Arm A)

(Arm B) No steroids

OTHER

Standard care without corticosteroid therapy.

Other: No steroids (Arm B)

(Arm C) Steroids with low dose for 10 days

EXPERIMENTAL

Dexamethasone 0.1 mg/kg from day 1 to day 5 and 0.05 mg/kg from day 6 to day 10.

Drug: Corticosteroids, low dose for 10 days

(Arm D) Steroids with low dose for 7 days

EXPERIMENTAL

Dexamethasone 0.1 mg/kg from day 1 to day 4 and 0.05 mg/kg from day 5 to day 7.

Drug: Corticosteroids, low dose for 7 days

(Arm E) Steroids with medium dose for 10 days

EXPERIMENTAL

Dexamethasone 0.2 mg/kg from day 1 to day 5 and 0.1 mg/kg from day 6 to day 10.

Drug: Corticosteroids, medium dose for 10 days

(Arm F) Steroids with medium dose for 7 days

EXPERIMENTAL

Dexamethasone 0.2 mg/kg from day 1 to day 4 and 0.1 mg/kg from day 5 to day 7.

Drug: Corticosteroids, medium dose for 7 days

Interventions

No steroids (Arm A) OTHER

Standard care for ARDS without corticosteroids.

(Arm A) No steroids

Corticosteroids, low dose for 7 days DRUG

Dexamethasone: low dose for 7 days

(Arm D) Steroids with low dose for 7 days

Corticosteroids, low dose for 10 days DRUG

Dexamethasone: low dose for 10 days

(Arm C) Steroids with low dose for 10 days

Corticosteroids, medium dose for 10 days DRUG

Dexamethasone: medium dose for 10 days

(Arm E) Steroids with medium dose for 10 days

No steroids (Arm B) OTHER

Standard care for ARDS without corticosteroids.

(Arm B) No steroids

Corticosteroids, medium dose for 7 days DRUG

Dexamethasone: medium dose for 7 days

(Arm F) Steroids with medium dose for 7 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Sheng-Yuan Ruan, MD, PhD

CONTACT

886223123456; syruan@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: July 17, 2026
• Study Start: June 15, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)