Identifying an Optimal Corticosteroid Dosage Regimen for Acute Respiratory Distress Syndrome

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • No steroids (Arm A)

    Other intervention

    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 intervention

    Standard care for ARDS without corticosteroids.

Treatment groups

300 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: (Arm A) No steroidsOther 1 intervention
Group B: (Arm B) No steroidsOther 1 intervention
Group C: (Arm C) Steroids with low dose for 10 daysExperimental treatment 1 intervention
Group D: (Arm D) Steroids with low dose for 7 daysExperimental treatment 1 intervention
Group E: (Arm E) Steroids with medium dose for 10 daysExperimental treatment 1 intervention
Group F: (Arm F) Steroids with medium dose for 7 daysExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
28 days

Secondary outcomes

1

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

Proportion of ventilator-free survival at day 28 between low dose (arm C and D) and medium dose (arm E and F) of corticosteroids.

Time frame
28 days
2

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

Proportion of ventilator-free survival at day 28 between long-course treatment (arms C and E) and short-course treatment (arms D and F)

Time frame
28 days
3

ICU mortality

Proportion of death in the ICU

Time frame
From ICU admission to discharge, an average of 21 days
4

60-day mortality

Proportion of death in 60 days

Time frame
60 days

Other outcomes

Sponsors and contacts

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