Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

NCT ID: NCT05401812

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Standard care without glucocorticoid therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Low dose and long treatment duration

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

Group Type: EXPERIMENTAL

Intravenous glucocorticoid therapy

Intervention Type: DRUG

Betamethasone, dexamethasone, or methylprednisolone

Low dose and short treatment duration

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

Group Type: EXPERIMENTAL

Intravenous glucocorticoid therapy

Intervention Type: DRUG

Betamethasone, dexamethasone, or methylprednisolone

Moderate dose and long treatment duration

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

Group Type: EXPERIMENTAL

Intravenous glucocorticoid therapy

Intervention Type: DRUG

Betamethasone, dexamethasone, or methylprednisolone

Moderate dose and short treatment duration

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

Group Type: EXPERIMENTAL

Intravenous glucocorticoid therapy

Intervention Type: DRUG

Betamethasone, dexamethasone, or methylprednisolone

Interventions

Intravenous glucocorticoid therapy

Betamethasone, dexamethasone, or methylprednisolone

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Moderate to severe ARDS with a P/F ratio < 200 mmHg

2. On invasive mechanical ventilation

3. The onset of ARDS < 72 hours

Exclusion Criteria

1. Age <20 years

2. Receiving systemic glucocorticoid therapy

3. Uncontrolled gastrointestinal bleeding

4. Terminal cancer

5. Post-operation or with large wound

6. Considered by the primary care doctor to be either definitely indicated or definitely contraindicated for glucocorticoid therapy

7. Anticipating to receive chemotherapy and immunotherapy in 3 months

8. Uncontrolled fungal infection

9. Post solid organ or bone marrow transplant

10. Severe influenza without anti-viral therapy

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

202012189MINB

Identifier Type: -

Identifier Source: org_study_id