Acute Respiratory Distress Syndrome
Conditions
Interventions
Experimental Group 1:Basic treatment combined with inhalation H057, 50mg (2mL) inhalation H057 each time, continuous nebulization inhalation until there are no droplets, 3 times/day, with an interval
Experimental Group 2:Combination therapy with inhalation H057 for basic treatment, inhaling 100mg (4mL) of H057 each time, continuously nebulizing until there are no droplets, 3 times/day, with an int
Experimental Group 3:Basic treatment combined with inhalation H057, 200mg (8mL) inhalation H057 each time, continuous nebulization inhalation until there are no droplets, 3 times/day, with an interval
Sponsors
The first affiliated hospital of zhengzhou university
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old, gender is not limited; 2. Diagnosis of ARDS according to the new global definition, no more than 48 hours from the signing of the informed consent form; 3. Meet all of the following criteria: Chest imaging: bilateral lung opacities can be seen on chest x-ray, which cannot be fully explained by pleural effusion, lung/lobar atelectasis, and pulmonary nodules; Pulmonary edema: respiratory failure that cannot be explained by heart failure or increased fluid load, and in the absence of risk factors, an objective evaluation (eg, cardiac ultrasonography) is required to rule out pulmonary edema with elevated hydrostatic pressure; With HFNC oxygen flow > = 30 L/min or noninvasive mechanical ventilation (NIV)/continuous postive airway pressure (CPAP) at least 5 cm H2O expiratory pressure, one of the following: 100mmHg<PaO2/FiO2<=300mmHg*; 148<SpO2/FiO2<=315 (if SpO2<=97%)*; *Blood gas and SpO2 measurements should be performed while the patient is comfortably resting and at least 30 minutes after changes in position, FiO2, or flow. 4. The subject or his/her agent signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients receiving invasive mechanical ventilation; 2. Patients with shock, hemodynamic instability and extrapulmonary organ failure; 3. Those with any of the following chronic organ damage or immunosuppression: Cardiac: Cardiac arrest within 4 weeks prior to screening; New York Heart Association cardiac function grade IV at screening; Myocardial infarction, severe/unstable angina, hemodynamic instability, or known left ventricular ejection fraction (LVEF) 1.5 upper limit of normal (Upper Limit of Normal, ULN) or creatinine clearance 50mmHg); 5. Patients with neuromuscular system diseases that impair autonomic ventilation; 6. Patients with suspected or known active tuberculosis; 7. Positive for hepatitis B surface antigen (HBsAg) and HBV-DNA > 1000 copies/mL or 200 IU/mL; positive for hepatitis C virus antibody (HCV-Ab); positive for human immunodeficiency virus antibody (HIV-Ab); Patients with Treponema pallidum antibody positive; 8. Patients who have used ulinastatin, cevilastat sodium for injection, Xuebijing, thymus peptide, immunoglobulin and immunosuppressants and other drugs that have an impact on neutrophil elastase and immune system within 28 days before enrollment; 9. Patients who cannot tolerate nebulized inhalation therapy; 10. Patients who are allergic to the active ingredients and excipients of this product or have allergies; 11. Those who have participated in other drug or medical device trials or are participating in other clinical trials within 3 months before the trial; 12. Pregnant women, lactating women and women with pregnancy plans within 6 months; 13. The investigator believes that the subject is not suitable to participate in the study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with PaO2/FiO2>300mmHg for at least 12 hours; | — |
Secondary
| Measure | Time frame |
|---|---|
| Start treatment (D1) until PaO2/FiO2>300mmHg is reached for the first time and lasts for at least 12 hours;Changes in PaO2/FiO2 compared to D1;Changes in SpO2/FiO2 compared to D1;The proportion of patients with at least one grade increase in PaO2/FiO2 (such as 100mmHg300mmHg; 200mmHg300mmHg);Proportion of patients with endotracheal intubation;Days from D1 to tracheal intubation;The proportion of patients who withdrew from HFNC;The number of days from D1 to HFNC evacuation;The individual chest X-ray score and RALE score in the Murray lung injury score should be used to evaluate the changes in the patient's chest X-ray compared to D1;Mechanical ventilation time of patients;ICU hospitalization days and total hospitalization days;The all-cause mortality rate of patients;Changes in the Pneumonia Severity Index (PSI) score compared to D1 in pneumonia patients;Changes in APACHE II score compared to D1;Changes in SOFA score compared to D1; | — |
Countries
China
Contacts
Public ContactYao Mengying
The first affiliated hospital of zhengzhou university
Outcome results
None listed