Glucocorticoid Therapy for Acute Respiratory Distress Syndrome
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
No Intervention: Control Standard care without glucocorticoid therapy. |
|
Experimental: 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. |
Drug: Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone
|
Experimental: 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. |
Drug: Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone
|
Experimental: 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. |
Drug: Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone
|
Experimental: 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. |
Drug: Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone
|
Outcome Measures
Primary Outcome Measures
- Ventilator-free survival [28 days]
Ventilator-free survival between control and intervention arms
Secondary Outcome Measures
- Glucocorticoid dose and ventilator-free survival [28 days]
Ventilator-free survival between low-dose and moderate-dose glucocorticoid groups
- Glucocorticoid treatment duration and ventilator-free survival [28 days]
Ventilator-free survival between long treatment duration and short treatment duration groups
- ICU mortality [Length of ICU stay up to 28 days]
Between-group difference in mortality at ICU discharge
- Hospital mortality [Length of hospital stay up to 60 days]
Between-group difference in mortality at hospital discharge
- 60-day mortality [60 days]
Between-group difference in mortality by day 60
- Oxygenation on day 7 [7 days]
Proportion of patients with a P/F ratio > 200 mmHg on day 7
- Rapid oxygenation improvement [3 days]
Change in P/F ratios between day 1 and day 3
- Successful liberation from mechanical ventilation [Up to 60 days]
Median time to successful liberation from mechanical ventilation
- Lymphocytopenia [7 days]
Proportion of lymphocytopenia on day 7
- Blood glucose level [10 days]
Peak blood glucose level during treatment
- Hyperglycemia [10 days]
Proportion of patients with hyperglycemia during treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Moderate to severe ARDS with a P/F ratio < 200 mmHg
-
On invasive mechanical ventilation
-
The onset of ARDS < 72 hours
Exclusion Criteria:
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Age <20 years
-
Receiving systemic glucocorticoid therapy
-
Uncontrolled gastrointestinal bleeding
-
Terminal cancer
-
Post-operation or with large wound
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Considered by the primary care doctor to be either definitely indicated or definitely contraindicated for glucocorticoid therapy
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Anticipating to receive chemotherapy and immunotherapy in 3 months
-
Uncontrolled fungal infection
-
Post solid organ or bone marrow transplant
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Severe influenza without anti-viral therapy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202012189MINB