Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT01478802
Eligibility Criteria:
Inclusion Criteria:
1. early ARDS (establishment of the diagnosis within the preceding 72 hours) according to the criteria of the American-European Consensus Conference (5),
2. Moderate-to-severe oxygenation disturbance \[defined as ratio of partial pressure of arterial oxygen (PaO2) to inspired oxygen fraction (FiO2)\<200 mmHg, while being ventilated with positive end-expiratory pressure (PEEP) set at ≥10 cmH2O for at least 12 hours,
3. age 18-75 years, body weight \>40 Kg,
Exclusion Criteria:
1. severe air leak (more than one chest tubes per hemithorax with persistent air leak for more than 72 hours),
2. systolic blood pressure lower than 90 mmHg and/or mean blood pressure lower than 65 mmHg, despite maximum support with fluids and vasopressor drugs (i.e., norepinephrine infusion rate exceeding 0.5 μg/kg/min,
3. significant heart disease (e.g. ejection fraction lower than 40%, history of pulmonary edema and active ischemic disease or myocardial infarction),
4. severe chronic obstructive pulmonary disease (COPD) or asthma (e.g. previous admission for COPD/asthma, chronic treatment with corticosteroids for COPD/asthma, and chronic CO2 retention more than 50 mmHg),
5. intracranial pathology with intracranial pressure \>20 mmHg, not responsive to maximum conservative treatment (e.g. hemorrhage, head injury, tumor, infection or acute ischemic stroke),
6. chronic interstitial lung disease with bilateral lung infiltrates,
7. lung biopsy or incision during the current admission,
8. previous lung transplantation or bone marrow transplantation, i) pregnancy,
9. immunosuppression, and
10. participation in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01478802
Study Brief:
Protocol Section:
NCT01478802