Acute Respiratory Distress Syndrome (ARDS) Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Sheng-Yuan Ruan, MD, PhD
syruan@ntu.edu.tw
886223123456
Time Frame
Start Date: 2025-06-15
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 300
Treatments
Other: (Arm A) No steroids
Standard care without corticosteroid therapy.
Other: (Arm B) No steroids
Standard care without corticosteroid therapy.
Experimental: (Arm C) Steroids with low dose for 10 days
Dexamethasone 0.1 mg/kg from day 1 to day 5 and 0.05 mg/kg from day 6 to day 10.
Experimental: (Arm D) Steroids with low dose for 7 days
Dexamethasone 0.1 mg/kg from day 1 to day 4 and 0.05 mg/kg from day 5 to day 7.
Experimental: (Arm E) Steroids with medium dose for 10 days
Dexamethasone 0.2 mg/kg from day 1 to day 5 and 0.1 mg/kg from day 6 to day 10.
Experimental: (Arm F) Steroids with medium dose for 7 days
Dexamethasone 0.2 mg/kg from day 1 to day 4 and 0.1 mg/kg from day 5 to day 7.
Sponsors
Leads: National Taiwan University Hospital

This content was sourced from clinicaltrials.gov