Actively Recruiting
Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
Led by Peking Union Medical College Hospital · Updated on 2024-06-04
300
Participants Needed
4
Research Sites
72 weeks
Total Duration
On this page
Sponsors
P
Peking Union Medical College Hospital
Lead Sponsor
P
Peking University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Sivelestat Sodium and Dexamethasone in the Treatment of ARDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with moderate-to-severe ARDS in the acute exacerbation phase who meet diagnostic criteria for moderate-to-severe ARDS
- Receiving tracheal intubation for mechanical ventilation within 72 hours after an episode of moderate-to-severe ARDS
- ARDS onset to randomized grouping within 72 hours as documented in medical records
- Patient volunteers to participate and signs an informed consent form
You will not qualify if you...
- Pregnancy or breastfeeding
- Brain death
- Advanced cancer or other terminal diseases
- History of allergy to Sivelestat Sodium and Dexamethasone
- Severe chronic obstructive pulmonary disease
- History of severe cardiovascular disease such as heart failure, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or heart/cerebral infarction within past six months
- Organ transplant or allogeneic stem cell transplant recipients
- Fatal active fungal infections
- Neuromuscular disease affecting voluntary breathing
- Genetic or acquired severe immunodeficiencies including HIV infection, chronic granulomatous disease, severe combined immunodeficiencies
- Signed Do Not Resuscitate (DNR) advance directive or treatment abandonment
- Currently participating in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
2
Luoyang Central Hospital
Luoyang, Henan, China
Not Yet Recruiting
3
Yanan University Affiliated Hospital
Yan’an, Shaanxi, China
Actively Recruiting
4
The Third Hospital of Mianyang
Mianyang, Sichuan, China
Not Yet Recruiting
Research Team
Y
Yan Chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here