Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

NCT05401812 | Withdrawn Phase 2

• 1 other identifier: 202012189MINB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Acute respiratory distress syndrome (ARDS) is a clinical syndrome of inflammatory lung injury characterized by increased pulmonary vascular permeability, loss of aerated lung tissue, severe hypoxemia and impaired compliance. Despite the advance in the critical care technology, the mortality of ARDS remains high in the last decades. Glucocorticoids have profound anti-inflammatory actions through the pleiotropic effects of the glucocorticoid receptor, which are considering a promising pharmacological therapy to mitigate the inflammatory lung injury and subsequent fibrosis in ARDS. Previous clinical trials have repeatedly tested the efficacy of glucocorticoid therapy in ARDS; however, the data about hard outcomes, such as mortality, are inconsistent between these studies. Investigators designed a 3x2 factorial trial of glucocorticoid therapy in ARDS to test the effects of glucocorticoid dosages (dose 0, dose 0.5 mg/kg, and dose 1 mg/kg of methylprednisolone equivalence) and durations (prolonged and short duration) on the treatment efficacy. In addition, investigators will measure the change of inflammatory biomarkers for post-hoc analysis to explore whether biomarkers could be used to guide patient selection and steroid tapering.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome; Corticosteroid; Glucocorticoid

Outcome Measures

Primary Outcomes (1)

• Ventilator-free survival

  Ventilator-free survival between control and intervention arms

  28 days

Secondary Outcomes (11)

• Glucocorticoid dose and ventilator-free survival

  28 days

• Glucocorticoid treatment duration and ventilator-free survival

  28 days

• ICU mortality

  Length of ICU stay up to 28 days

• Hospital mortality

  Length of hospital stay up to 60 days

• 60-day mortality

  60 days

Study Arms (5)

Control

NO INTERVENTION

Standard care without glucocorticoid therapy.

Low dose and long treatment duration

EXPERIMENTAL

Methylprednisolone equivalent dose 0.5 mg/kg/day for 5 days, followed by 0.25 mg/kg/day for 5 days.

Drug: Intravenous glucocorticoid therapy

Low dose and short treatment duration

EXPERIMENTAL

Methylprednisolone equivalent dose 0.5 mg/kg/day for 4 days,, followed by 0.25 mg/kg/day for 3 days.

Drug: Intravenous glucocorticoid therapy

Moderate dose and long treatment duration

EXPERIMENTAL

Methylprednisolone equivalent dose 1 mg/kg/day for 5 days, followed by 0.5 mg/kg/day for 5 days.

Drug: Intravenous glucocorticoid therapy

Moderate dose and short treatment duration

EXPERIMENTAL

Methylprednisolone equivalent dose 1 mg/kg/day for 4 days, followed by 0.5 mg/kg/day for 3 days.

Drug: Intravenous glucocorticoid therapy

Interventions

Intravenous glucocorticoid therapy DRUG

Betamethasone, dexamethasone, or methylprednisolone

Low dose and long treatment duration; Low dose and short treatment duration; Moderate dose and long treatment duration; Moderate dose and short treatment duration

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe ARDS with a P/F ratio \< 200 mmHg
• On invasive mechanical ventilation
• The onset of ARDS \< 72 hours

You may not qualify if:

• Age \<20 years
• Receiving systemic glucocorticoid therapy
• Uncontrolled gastrointestinal bleeding
• Terminal cancer
• Post-operation or with large wound
• Considered by the primary care doctor to be either definitely indicated or definitely contraindicated for glucocorticoid therapy
• Anticipating to receive chemotherapy and immunotherapy in 3 months
• Uncontrolled fungal infection
• Post solid organ or bone marrow transplant
• Severe influenza without anti-viral therapy

Sponsors & Collaborators

• National Taiwan University Hospital: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2022
• First Posted: June 2, 2022
• Study Start: July 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: April 30, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03