Last updated on April 2018

Treprostinil Sodium Inhalation for Patients At High Risk for ARDS

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Age: Between 18 - 75 Years
  • Gender: Male or Female

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 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 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 Veltri), Iloprost (Ventavis), Treprostinil (Orenitram, oral) (Remodulin, IV or SC)]
  18. Patient has a language barrier

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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