acute respiratory distress syndrome (ARDS)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=18 years; 2. According to the Berlin definition—severe ARDS (PaO2/FiO2 =5 cmH2O), onset <=48 hours; 3. Assessed as sepsis-related ARDS (infection confirmed or highly suspected); 4. Currently on mechanical ventilation or expected to require mechanical ventilation within 24 hours; 5. Patient or legal representative has signed informed consent (ICU emergency consent process applicable).
Exclusion criteria
Exclusion criteria: 1. Known allergy to ALA; 2. Pregnant or breastfeeding; 3. Expected to die within 24 hours or have terminal illness; 4. Severe uncontrolled bleeding; 5. ALT/AST >5×ULN; 6. Currently receiving investigational drugs or high-dose combined antioxidant therapy that conflict with this trial; 7. Use of high-dose ALA within the past 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The absolute value and changes of PaO2/FiO2; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the SOFA score;The number of days the ventilator was used within 28 days;The rate of new initiation of renal replacement therapy within 28 days;Changes in inflammatory and oxidative stress biomarkers (IL-6, TNF-a, MDA, SOD, GSH); | — |
Countries
China
Contacts
Weifang People's Hospital