Activated Protein C versus placebo in the treatment of Inflammatory or Infectious ALI/ARDS (INFALI): a pathophysiological study on pulmonary microvascular permeability, apoptosis, inflammation and coagulation.
Recruiting
- Conditions
- Acute Lung Injury (ALI), Acute Respiratory Distress Syndrome (ARDS)
- Registration Number
- NL-OMON21017
- Lead Sponsor
- VU University Medical Center (VUmc), department of Intensive Care
- Brief Summary
will be written after analysis of results
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 106
Inclusion Criteria
1. age 18 - 75 years
2. weight < 135 kg
Exclusion Criteria
1. APACHE II score: 25 and more
2. 2 or more failing organs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 67-Gallium pulmonary leak index (PLI)<br>
- Secondary Outcome Measures
Name Time Method 1. Lung Injury Score<br /><br>2. inflammatory mediators/biomarkers (blood, mini-BAL)<br /><br>3. coagulation and fibrinolysis markers (blood, mini-BAL)<br /><br>4. apoptosis markers (blood, mini-BAL)<br /><br>5. mortality<br /><br>6. extra-vascular lung water <br /><br>7. gas exchange (compliance, PaO2/FiO2)<br /><br>8. radiographic abnormalities (X-ray, CT)<br /><br>9. change of ventilatory mode (noninvasive vs. invasive)<br /><br>10. duration of mechanical ventilation <br />