SURFACEN in ARDS Adults. Phase II
Phase 2
Completed
- Conditions
- Acute Respiratory Distress Syndrome in adults
- Registration Number
- RPCEC00000126
- Lead Sponsor
- ational Centre of Animal and Plants Health(CENSA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 72
Inclusion Criteria
1. Presenceof ARDS inthe first 24hours ofdiagnosis, diagnostic criteriagivenabove. 2. PEEP> 5 cm H2O. 3. Patientswhose relativesgive theirwritten consentto participatein the study. 4. Age between 18 and 75,inclusive.
Exclusion Criteria
1.Pregnant women, breast feedingor post partum. 2.Chronic Obstructive Pulmonary Disease(COPD). 3.Hipersensibilidad to SURFACEN or other component of the formulation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PaO2/FiO2 ratio (favorable when it is >=200). Measurement time: Group A: 1h, 4h and 8h after each dose. Group B: 1h, 4h and 8h after hemodynamic stabilization until complete 3 days
- Secondary Outcome Measures
Name Time Method