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 @ 2:17 PM
Ignite Modification Date:
2025-12-24 @ 2:17 PM
NCT ID:
NCT02370095
Eligibility Criteria:
Inclusion Criteria:
1. Adults age 18-75 years.
2. Acute onset need for 4 liters per minute (LPM) or more of supplemental oxygen to maintain Arterial partial pressure of oxygen (PaO2) \> 60 mmHg or arterial O2 saturation \> 90% by pulse oximetry.
3. Acute unilateral pulmonary infiltrate/s on chest radiograph with no clinical evidence of left-sided heart failure. Bilateral infiltrates are acceptable as long as all other inclusion/exclusion criteria are met.
Exclusion Criteria:
1. No consent/inability to obtain consent
2. Presence of pulmonary embolism
3. Known diffuse alveolar hemorrhage from vasculitis
4. Known pre-existing severe obstructive or restrictive lung disease (FEV 1 \< 40% predicted, total lung capacity (TLC) \< 50 % predicted) or need for long-term supplemental oxygen therapy
5. Known significant left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) \< 45% on echocardiogram.
6. Mean arterial pressure \< 65 mmHg
7. Need for norepinephrine or dopamine dose \> 12 mcg to maintain mean arterial pressure (MAP) \> 65 mmHg
8. Severe chronic liver disease (Child-Pugh Score 11-15)
9. Moribund patient not expected to survive 24 hours
10. Corrected QT interval (QTc) interval \> 500 ms on screening electrocardiogram
11. Pregnancy or breast feeding (Women of childbearing potential, defined as \< 60 years of age, will require pregnancy testing.)
12. Burns \> 40% total body surface
13. Acute Neurological Disease (that may impair the ability to ventilate without assistance)
14. Imminent need for intubation or non-invasive ventilation
15. Patient is Do Not Resuscitate/Do Not Intubate
16. Patient has a tracheotomy
17. Patient is currently receiving prostacyclin therapy \[Epoprostenol (Flolan or Veletri), Iloprost (Ventavis), Treprostinil (Orenitram, oral) (Remodulin, IV or SC)\]
18. Patient has a language barrier
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02370095
Study Brief:
Protocol Section:
NCT02370095