Acute Respiratory Distress Syndrome
Conditions
Interventions
Experimental group: SURFACEN® + oxygenation + mechanical ventilation. Administration of 100 mg (4 mL) of SURFACEN® be indicated endotracheally (instillation through a tube) every 8 hours for a maximum
Sponsors
National Centre of Animal and Plants Health (CENSA)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Related to safety. Adverse Events (AE). Measuring time: An hour after first dose until 28 days. - Type of AE (Name of event) - Time to occurrence of AE (hours, minutes or days, between product administration and the occurrence of AE) - Duration of the AE (hours, minutes or day that is present the AE) - Severity/Seriousness of the AE (Serious, Not serious) - Intensity of the AE (Mild, Moderate, Severe) - Causality relationship (Definitive, Very likely, Likely, Possible, Unrelated, Unknown) - Attitude (Without change, Temporary stop, Permanent stop) - Treatment of the AE (Treatment for the AE). - Result of the AE (Reversible effect, Irreversible effect, Death, or Loss to follow-up the patient). - Lot of SURFACEN® (batch number of the product) Related to effectiveness Changes in PaO2/FiO2 (value provided by the Blood gas analyzer of Intensive Care Unit-ICU). Measuring time: at baseline, an hour after each dose. pH (Value provided by the Blood gas analyzer of ICU). Measuring time: at baseline, an hour after each dose. DA-aO2 (value calculated from the formula [Fi O2 (PB-PH 2 O) -PaCO2] -PaO2 where PB = 760mmHg, PH 2 O = 47mmHg, taking into account normal PaCO2 references (35-48 mmHg (4.7 - 6.4 kPa) men 32-45 mmHg (4.3 - 6.0 kPa) women), PaO2 83-108 mmHg and pH 7.35-7.45). Measuring time: at baseline, an hour after each dose. Ventilatory mode (pressure, volume). Measuring time: at baseline, an hour after each dose. Tidal volume (Vt L / min given by the ventilator available in the ICU). Measuring time: at baseline, an hour after each dose. Respiratory Rate (RR in minutes (min), given by the ventilator in the ICU). Measuring time: at baseline, an hour after each dose. Peak pressure (Pr cmH2O peak given by the ventilator in the ICU). Measuring time: at baseline, an hour after each dose. Airway Plateau Pressure (PPlat in cmH2O given by the ventilator in the ICU). Measuring time: at baseline, an hour after each dose. Relationship inspiration / expiration (I / E, given by | — |
Countries
Cuba
Contacts
Public ContactYisel Avila Albuerne
National Coordinating Center of Clinical Trials (CENCEC)
Outcome results
None listed