Treprostinil Sodium Inhalation for Patients At High Risk for ARDS
Condition: Respiratory Distress Syndrome, Adult
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Intervention: Treprostinil Inhalation Solution; Placebo
Intervention description: Treprostinil inhalation solution administered as blinded marketed product; Supplied by the manufacturer and similar to the active drug but containing no Treprostinil
Intervention MeSH terms: Treprostinil; Pharmaceutical Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ARDS; Acute Lung Injury; Acute Respiratory Failure

Summary:

      Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressing lung disease caused by a
      number of factors including pneumonia, sepsis and acute trauma that leads to reduced lung
      function and breathlessness. There are no pharmacological treatments approved for the
      treatment of ARDS. This pilot trial will study the safety and efficacy of Treprostinil sodium
      by inhalation for preventing the progression of acute hypoxemic respiratory failure to
      positive pressure ventilation and/or ARDS in patients at high risk.
    

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