acute respiratory distress syndrome
Conditions
Interventions
control group (without cilvelestat sodium):None
Experimental group (with cilvelestat sodium):None
Sponsors
General Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Male or female, =18 years old; 2. Meet the new global diagnostic criteria for ARDS 2023 3.Patients who can administer the drug within 72 hours of the onset of ARDS 4.Be able to understand and comply with the requirements of the agreement, voluntarily participate in the study, and sign the informed consent;
Exclusion criteria
Exclusion criteria: 1.The patients who are concurrently enrolled in other investigational clinical trials. 2.Women who are pregnant, lactating, or of childbearing potential. 3.Ptients or their familily refuse to sign the informed consent; 4.Allergic to the experimental drug 5.Severe chronic respiratory diseases: autoimmune diseases involving the lungs and chronic respiratory failure, such as moderate-to-severe chronic obstructive pulmonary disease (FEV1 < 70%pred or clinically significant airway obstructive disease), bronchiectasis or pulmonary interstitial fibrosis (more than 20% lung volume); Patients with diaphragmatic or respiratory weakness; 6.Patients with advanced tumors or cachexia (with an expected survival prognosis of no more than 3 months) 7.Patients with intracranial hypertension, cerebral hernia and deep coma;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxygenation index (PaO2/FiO2) and SpO2/FiO2 on the 7th day of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory examination: WBC, NEU%, NLR, CRP, PCT, IL-6;Chest radiograph;ABG: Oxygenation index PaO2/FiO2, SpO2/FiO2, PaO2, SpO2 on the 3rd and 5th day of treatment;Duration of no respiratory support in 28 days ;Duration of non-mechanical ventilation in 28 days ;Length of ICU stay;survival;Total length of stay within 28 days after medication ; | — |
Countries
China
Contacts
Public Contactkeliang xie
Tianjin Medical University General Hospital
Outcome results
None listed