Acute respiratory distress syndrome (ARDS)
Conditions
Interventions
Experimental group:rhKGF-2 drug product
Control group:Maintain previous treatment
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-80; 2.Definitely diagnosed as Acute Respiratory Distress Syndrome according to the Berlin Definition; 3.Patients with a PaO2/FiO2 ratio < 200 mmHg undergoing invasive mechanical ventilation via endotracheal tube. 4.Patients diagnosed with ARDS within 72 hours prior to enrollment. 5.Those who have no plan for childbearing within the next year and agree to take effective contraceptive measures during the study period; women of childbearing age must have a negative serum pregnancy test. 6.Subjects fully understand the purpose of the trial, the nature and methods of the drug study, and the possible adverse reactions. They voluntarily sign the informed consent form to participate in the trial and agree to comply with the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1.Treatment with inhaled pulmonary vasodilators (such as nitric oxide or prostacyclin). 2.Those who are currently receiving or are scheduled to receive Extracorporeal Membrane Oxygenation (ECMO) therapy during the trial period. 3.Those with an expected survival of less than 3 months due to causes other than respiratory failure. 4.Those who have experienced a cardiovascular or cerebrovascular event within 3 months prior to dosing, such as unstable angina pectoris, congestive heart failure, myocardial infarction within the previous 12 months, hemodynamic instability, or known left ventricular ejection fraction (LVEF) < 40%, or clinically significant rhythm or conduction abnormalities. 5.Subjects who cannot tolerate single-use bronchoscopic imaging catheter examination, including but not limited to the following conditions: active massive hemoptysis; severe hypertension and arrhythmia; myocardial infarction or history of unstable angina pectoris within 4-6 weeks prior to screening; severe cardiac dysfunction; uncorrectable bleeding tendency (platelet count < 60 × 10^9/L), such as severe coagulation disorders, uremia, and severe pulmonary arterial hypertension; severe superior vena cava syndrome; suspected aortic aneurysm; multiple pulmonary bullae. 6.Subjects with a history of severe allergic reaction or who are allergic or hypersensitive to any component of the formulation. 7.Women who are breastfeeding or pregnant; 8.Those who have participated in any drug clinical trial within the past 3 months; 9.Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Sereve Adverse Events;Incidence of Adverse Events;Various Laboratory Parameters; | — |
Countries
China
Contacts
Public ContactSong Yuanlin
Zhongshan Hospital, Fudan University
Outcome results
None listed