Respiratory Distress Syndrome, Adult
Conditions
Keywords
Pneumonia, Aspiration, Drowning, inhalation
Brief summary
This study will determine if administration of an suspension of calfactant, a lung surfactant, intratracheally in patients with Direct Acute Respiratory Distress Syndrome within 48 hours of requiring mechanical ventilation can decrease the mortality in patients with lethal disease and shorten the course of respiratory failure in patients with sub-lethal disease.
Detailed description
Recruitment limited to direct adult respiratory distress syndrome patients who have been intubated \<48 hours. Origin of ARDS must be infectious pneumonia, aspiration of stomach contents, near drowning, smoke inhalation without pulmonary burn, inhaled industrial gas.
Interventions
DRUGCalfactant
Intratracheal Instillation of 0.5 mL/cm of height of 60 mg/mL suspension in two aliquots at study entry. Repeat dosing 12 hours later if criteria are met.
Administration of 0.5 ml/cm height of air at study entry into the trachea. Repeat dosing at 12 hours if criteria are met
Sponsors
Pneuma Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Respiratory failure due to diffuse infectious pneumonia, aspiration, near drowning, smoke inhalation or industrial gas 2. Less than 48 hours of mechanical ventilation 3. Informed consent
Exclusion criteria
1. Pre-existing lung disease 2. coma 3. limited therapeutic goals (do not resuscitate, etc.) 4. failure of another vital organ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality Rate | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Duration of mechanical ventilation | 90 days |
Countries
Australia, Canada, Israel, New Zealand, South Korea, United States
Outcome results
None listed