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:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT00624650
Eligibility Criteria:
Inclusion Criteria:
Acute onset of:
1. PaO2/FiO2 less than or equal to 300.
2. Bilateral infiltrates consistent with pulmonary edema on the frontal chest radiograph.
3. Requirement for positive pressure ventilation through an endotracheal tube or tracheostomy.
4. No clinical evidence of left atrial hypertension that would explain the pulmonary infiltrates. If measured, pulmonary arterial wedge pressure less than or equal to 18 mmHg.
Exclusion Criteria:
1. Age younger than 18 years old.
2. Greater than 24 hours since all inclusion criteria first met.
3. Neuromuscular disease that impairs ability to ventilate without assistance, such as C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain-Barré syndrome, myasthenia gravis, or kyphoscoliosis (see Appendix I.A).
4. Pregnancy (negative pregnancy test required for women of child-bearing potential).
5. Severe chronic respiratory disease (see Appendix I.C).
6. Severe Chronic Liver Disease (Child-Pugh 11 - 15, see Appendix I.E)
7. Weight \> 160 kg.
8. Burns greater than 70% total body surface area.
9. Malignancy or other irreversible disease or conditions for which 6-month mortality is estimated to be greater than 50 % (see Appendix I.A).
10. Known cardiac or vascular aneurysm.
11. Contraindications to femoral arterial puncture - platelets \< 30, bilateral femoral arterial grafts, INR \> 3.0.
12. Not committed to full support.
13. Participation in other experimental medication trial within 30 days.
14. Allergy to intravenous lasix or any components of its carrier.
15. History of severe CHF - NYHA class ≥ III, previously documented EF \< 30%.
16. Diffuse alveolar hemorrhage.
17. Presence of reactive airway disease (active will be defined based on recent frequency and amounts of MDI's use and steroids to control the disease).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00624650
Study Brief:
Protocol Section:
NCT00624650