Glucocorticoid Therapy for Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

A Factorial Trial of Glucocorticoid Therapy in Acute Respiratory Distress Syndrome: Optimizing Dosing Regimen and Developing Biomarker-guided Treatment

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05401812
• Other study ID #: 202012189MINB
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: May 2022
• Source: National Taiwan University Hospital
• Contact: Sheng-Yuan Ruan
• Phone: 886223123456
• Email: 018477[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 30, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Intravenous glucocorticoid therapy
Betamethasone, dexamethasone, or methylprednisolone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free survival	Ventilator-free survival between control and intervention arms	28 days
Secondary	Glucocorticoid dose and ventilator-free survival	Ventilator-free survival between low-dose and moderate-dose glucocorticoid groups	28 days
Secondary	Glucocorticoid treatment duration and ventilator-free survival	Ventilator-free survival between long treatment duration and short treatment duration groups	28 days
Secondary	ICU mortality	Between-group difference in mortality at ICU discharge	Length of ICU stay up to 28 days
Secondary	Hospital mortality	Between-group difference in mortality at hospital discharge	Length of hospital stay up to 60 days
Secondary	60-day mortality	Between-group difference in mortality by day 60	60 days
Secondary	Oxygenation on day 7	Proportion of patients with a P/F ratio > 200 mmHg on day 7	7 days
Secondary	Rapid oxygenation improvement	Change in P/F ratios between day 1 and day 3	3 days
Secondary	Successful liberation from mechanical ventilation	Median time to successful liberation from mechanical ventilation	Up to 60 days
Secondary	Lymphocytopenia	Proportion of lymphocytopenia on day 7	7 days
Secondary	Blood glucose level	Peak blood glucose level during treatment	10 days
Secondary	Hyperglycemia	Proportion of patients with hyperglycemia during treatment	10 days