SIRS/ARDS
Conditions
Interventions
Trial group:Standard medication regimen of sivelestat sodium: 4.8mg/kg/day, after dissolving in normal saline, add a daily amount of sivelestat sodium to 250-500ml normal saline (or 5% glucose solutio
Control group:Conventional treatment, without the use of sivelestat sodium
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18-75 years old, male or female. 2. Diagnostic criteria of Sirs: at least 2 of the following 4 items were met (proposed by the American Association of critical care medicine in 1992): (1) Body temperature > 38 degrees C or 90 beats / min; (3) Respiration > 20 beats / min or PaCO2 < 32 mmHg; (4) The number of white blood cells was more than 12 * 10^9 / L or < 4 *10^9 / L, or the number of rod-shaped nuclear cells (immature white blood cells) was more than 10%. 3. The diagnostic criteria of ARDS were as follows: Hypoxemia: PaO2 / FiO2 <= 300MMHG; (Note: Patients with PaO2 / FiO2 < 100 mmHg are not eligible for this study.) Chest X-ray showed infiltrative shadows in both lungs; When the pulmonary artery wedge pressure can be measured, the pulmonary artery wedge pressure is less than or equal to 18 mmHg; if the pulmonary artery wedge pressure cannot be measured, there is no clinical manifestation of increased left atrial pressure. 4. According to Murray lung injury score standard, the total score of 4 items was greater than 6 points (when lung compliance could not be measured, the total score of other three items was greater than 4 points). 5. Subjects who did not participate in the drug test within three months. 6. Informed consent was signed by the subjects or their agents. 7. There must be objects with mechanical ventilation (both invasive and noninvasive).
Exclusion criteria
Exclusion criteria: 1. Patients with 4 or more multiple organ injuries including lung. 2. According to the multiple organ failure (MODS) score (see Table 2), patients who meet one of the following two items. (1) Oxygenation index < 100 mmHg; (2) The subjects whose scores of the other three organ systems except the lung were more than 2 points (excluding 2 points). 3. Ali caused by burn and trauma, Ali patients with severe chronic respiratory diseases. (Note: severe chronic respiratory disease refers to pulmonary interstitial fibrosis, severe chronic obstructive pulmonary disease, extensive bronchiectasis, etc.) 4. Congestive heart failure, diffuse pulmonary infection, severe systemic infection and other diseases that affect the diagnosis. 5. The object of allergic constitution. 6. Pregnant, lactating and pregnant women. 7. Patients with severe primary diseases (tumor, hematologic disease, uncontrolled diabetes, etc.) that affect 90 day survival. 8. Patients with mental disorders. 9. Patients who cannot be treated effectively. 10. Patients who are not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function improvement rate (main effect);SIRS symptom improvement rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ICU withdrawal rate and withdrawal time;mechanical ventilation withdrawal rate and withdrawal time;30th, 60th, and 90th day survival; | — |
Countries
china
Contacts
Public ContactLi Feng
Shanghai Public Health Clinical Center
Outcome results
None listed