SURFACEN in ARDS. Adults. Phase IV
Phase 4
Recruiting
- Conditions
- Acute Respiratory Distress Syndrome
- Registration Number
- RPCEC00000198
- Lead Sponsor
- ational Centre of Animal and Plants Health (CENSA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 184
Inclusion Criteria
1. Diagnosis of ARDS, according to the new definition of ARDS Berlin
2. Patient or member family frontline which expresses voluntariness written entering the study by signing the informed voluntary consent
3. 18 years and older.
Exclusion Criteria
1. Pregnant and postpartum women
2. Chronic obstructive pulmonary disease (COPD).
3. Patient at the time of inclusion is receiving other investigational drug.
4. Prior knowledge of a known allergy or sensitivity to SURFACEN® or any component of the formulation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serious adverse events in relation to the causality (Serious AE with definite, very likely or likely causal relationship). Measuring time: first hour after the 1st dose until to 28 days
- Secondary Outcome Measures
Name Time Method