Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

National Taiwan University

Status and phase: Withdrawn; Phase 2

Conditions: Acute Respiratory Distress Syndrome

Treatments: Drug: Intravenous glucocorticoid therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05401812

202012189MINB

Details and patient eligibility

About

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.

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 5 patient groups

Control

No Intervention group

Description:

Standard care without glucocorticoid therapy.

Low dose and long treatment duration

Experimental group

Description:

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

Treatment:

Drug: Intravenous glucocorticoid therapy

Low dose and short treatment duration

Experimental group

Description:

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

Treatment:

Drug: Intravenous glucocorticoid therapy

Moderate dose and long treatment duration

Experimental group

Description:

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

Treatment:

Drug: Intravenous glucocorticoid therapy

Moderate dose and short treatment duration

Experimental group

Description:

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

Treatment:

Drug: Intravenous glucocorticoid therapy