Acute Respiratory Distress Syndrome
Conditions
Interventions
Organ-on-a-Chip-Guided Group:Organ-on-a-Chip-Guided Dexamethasone Administration
Routine Treatment Group:Dexamethasone 10 mg/day, administered intravenously for 5 consecutive days.
Patients undergoing partial lung resection:None
Acute respiratory distress syndrome (ARDS) group:None
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Project 1 Patients Undergoing Lung Surgery: Patients who require partial lung resection due to medical conditions and meet the surgical criteria. ARDS Patients: 1. Patients taking glucocorticoids for a long term; 2. Patients who have participated in clinical trials within 3 months before randomization; 3. Pregnant or lactating women; 4. Patients with severe conditions who are expected to die within 48 or 72 hours. Project 2: 1. Aged >= 18 years old; 2. Moderate to severe ARDS patients who are diagnosed within 48 hours, receiving mechanical ventilation (with PaO2/FiO2 = 5 cmH2O), and whose ARDS diagnosis conforms to the 2012 Berlin Definition; 3. Patients who agree to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Project 1 Patients Undergoing Lung Surgery: 1. Patients with pulmonary infection and chronic lung diseases (including chronic obstructive pulmonary disease, pulmonary fibrosis, silicosis, pulmonary tuberculosis, etc.); 2. Patients for whom informed consent cannot be obtained. Project 1 ARDS Patients: 1. Patients taking glucocorticoids for a long term or for whom informed consent cannot be obtained; 2. Pregnant or lactating women; 3. Patients with severe conditions who are expected to die within 48 or 72 hours. Project 2: 1. Aged = 40 kg/m²); 11. Patients who received glucocorticoid treatment before enrollment (cumulative dose > 300 mg prednisolone or its equivalent within 21 days, or > 15 mg/d prednisolone within 7 days before enrollment); 12. Patients who used other immunosuppressants (including PD-1 and PDL-1 inhibitors) or cytotoxic drugs within 3 weeks before enrollment; 13. Patients with known contraindications to glucocorticoid use or active glaucoma and other such diseases; 14. Patients already participating in other clinical trials; 15. Other conditions deemed unsuitable for participation in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving a reduction >2 points in the Lung Injury Score (LIS) at Day 5; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day hospital length of stay (LOS);28-Day All-Cause Mortality;Proportion of Patients Receiving Rescue Therapy by Day 28;Organ Support-Free Days (OSFDs) through Day 28;SOFA and APACHE II Scores at Day 6 Post-Enrollment;28-Day Incidence of Adverse Events;Serum Cytokine Concentrations at Day 6 Post-Enrollment;28-day ICU length of stay (LOS); | — |
Countries
China
Contacts
Public ContactLing Sang
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed