Acute respiratory distress syndrome (ARDS)
Conditions
Interventions
experimental group:Sivelestat sodium 4.8mg/kg/d continuous intravenous pumping
control group:none
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Men and women are not limited, aged 18 to 70 years; 2. Patients who meet the sepsis3.0 criteria (infection or suspected infection + ?SOFA >= 2 points) diagnosed with sepsis, with new or worsening of the original respiratory symptoms within 7 days; 3. Chest imaging X-ray or lung CT showing bilateral lung infiltrates that cannot be fully explained by pleural effusion, lobe/atelectasis and nodular shadows; 4. Respiratory failure that cannot be explained by heart failure or fluid overload; 5. PEEP during invasive ventilation or CPAP during non-invasive ventilation >= 5cmH2O for more than 15 minutes, blood gas analysis PaO2/FiO2 <= 300mmHg after the state is stable; 6. Classification of acute respiratory distress syndrome: mild 200<PaO2/FiO2<=300mmHg, moderate 100<PaO2/FiO2<=200mmHg, severe PaO2/FiO2<=100mmHg.
Exclusion criteria
Exclusion criteria: 1. Patients who participate in other exploratory clinical studies at the same time; 2. Pregnant, lactating women or women who may be pregnant; 3. The patient or family member refuses to sign the informed consent; 4. Chronic respiratory failure, such as moderate-to-severe chronic obstructive pulmonary disease (FEV1 <70% pred or clinically significant airway obstructive disease), bronchiectasis or pulmonary fibrosis (with an area of more than 20% of the lung volume) .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygenation Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mechanical ventilation time;White blood cell count;C reactive protein;IL-6;IL-10;Tumor necrosis factor-a;length of hospital stay;length of ICU stay;28-day mortality; | — |
Countries
China
Contacts
Public ContactSun Tongwen
the First Affiliated Hospital of Zhengzhou University
Outcome results
None listed