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Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
Sponsor: Peking Union Medical College Hospital
Summary
The goal of this clinical trial is to evaluate the efficacy and safety of Sivelestat sodium and dexamethasone in the treatment of patients with moderate to severe ARDS. The main questions it aims to answer are: * Is Sivelestat sodium more effective in the treatment of patients with moderate to severe ARDS compared with placebo? * Is dexamethasone more effective in the treatment of patients with moderate to severe ARDS compared with placebo? Participants will receive Sivelestat sodium, dexamethasone or placebo. Researchers will compare the efficacy and safety of Sivelestat sodium, dexamethasone and placebo.
Official title: Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS: a Pilot Study of a Prospective, Multicenter, Double-blind, Double-mock Randomized Controlled Clinical Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-04-15
Completion Date
2025-09-01
Last Updated
2024-06-04
Healthy Volunteers
No
Conditions
Interventions
Sivelestat sodium
Sevilastat sodium 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone
Dexamethasone 10 mg IV once a day for 5 days or until extubation (within 5 days)
Sivelestat sodium placebo
Sivelestat sodium placebo 4.8 mg/kg/d IV continuous infusion for 14 days or ICU length of stay (within 14 days)
Dexamethasone placebo
Dexamethasone placebo 10 mg IV once a day for 5 days or until extubation (within 5 days)
Locations (4)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Luoyang Central Hospital
Luoyang, Henan, China
Yanan University Affiliated Hospital
Yan’an, Shaanxi, China
The Third Hospital of Mianyang
Mianyang, Sichuan, China