Treprostinil Sodium Inhalation for Patients At High Risk for ARDS

• Status: Terminated
• Trial end date: 2017-11-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: United Therapeutics
• Treatments: Pharmaceutical Solutions; Treprostinil

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