PHASE II RANDOMIZED, INTERVENTION VERSUS NON- INTERVENTION, MULTI- CENTER STUDY OF THE EFFECTS OF THYROID HORMONE (T3) ON SAFETY/TOLERABILITY AND OXYGENATION IN SUBJECTS WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)
It is hypothesized that instillation of Liothyronine Sodium (T3) into the airspace will be safe, well tolerated, and will increase alveolar fluid clearance and decrease inflammation in patients with ARDS, reflected in improved oxygenation index (OI) and oxygenation saturation index (OSI).
∙ Study population is critically ill patients requiring mechanical ventilatory support for ARDS in an intensive care unit.
• Adults (≥18 years of age).
• Male or female (non-pregnant).
• Clinical diagnosis of ARDS (all are required):
‣ Onset: \<= 7 days.
⁃ Chest x-ray: Bilateral Patchy Opacities, Infiltrates.
⁃ Mechanical Vent Support: PEEP or CPAP Support \>= 5 cm H2O.
⁃ Pulmonary Edema: Not fully explained by cardiogenic etiology.
⁃ Hypoxia: PaO2/FIO2 Ratio \<300, or O2Sat/FIO2 Ratio \<315.
• On mechanical ventilatory support.
• Capable of giving informed consent directly or from the subject's legally authorized representative (LAR) as determined by the site Principal Investigator and/or Sub- Investigators.