Clinical trial NCT05401812: Glucocorticoid Therapy for Acute Respiratory Distress Syndrome
Official title: A Factorial Trial of Glucocorticoid Therapy in Acute Respiratory Distress Syndrome: Optimizing Dosing Regimen and Developing Biomarker-guided Treatment
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute Respiratory Distress Syndrome
Corticosteroid
Glucocorticoid
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Ventilator-free survival
timeFrame: 28 days
Secondary outcomes:
measure: Glucocorticoid dose and ventilator-free survival
timeFrame: 28 days
measure: Glucocorticoid treatment duration and ventilator-free survival
timeFrame: 28 days
measure: ICU mortality
timeFrame: Length of ICU stay up to 28 days
measure: Hospital mortality
timeFrame: Length of hospital stay up to 60 days
measure: 60-day mortality
timeFrame: 60 days
measure: Oxygenation on day 7
timeFrame: 7 days
measure: Rapid oxygenation improvement
timeFrame: 3 days
measure: Successful liberation from mechanical ventilation
timeFrame: Up to 60 days
measure: Lymphocytopenia
timeFrame: 7 days
measure: Blood glucose level
timeFrame: 10 days
measure: Hyperglycemia
timeFrame: 10 days
Other outcomes:
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