Phase II Randomized, Intervention Versus Non-Intervention, Multi-Center Study of the Effects of Thyroid Hormone (T3) on Extravascular Lung Water (EVLW) in Subjects with Acute Respiratory Distress Syndrome (ARDS)
Study objective: To determine the safety and tolerability of Thyroid Hormone (T3) delivery into the lungs of Acute Respiratory Distress Syndrome (ARDS) patients, and to measure the effect of T3 on extravascular lung water in ARDS patients.
• Chest x-ray: bilateral pulmonary infiltrates
• Hypoxemia: PaO2:FIO2 ratio <200
• Volume status: wedge and CVP<18 Main inclusion criteria:
• Adults (≥18 years of age), non-pregnant
• On mechanical ventilatory support
• Inadequate medical history for determining inclusion/exclusion criteria, as determined by the Principal Investigator and/or Sub-Investigators.
• Unlikely to complete the protocol with clinic follow-up after discharge, as determined by the Principal Investigator and/or Sub-Investigators or hospice status.
• Active drug/alcohol use with positive drug screen or alcohol level on admission.
• Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test.
• Prior history of cardiovascular disease including:
• Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120 mmHg),
• Sustained ventricular arrhythmia in the past 3 months (duration > 30 seconds)
• Coronary artery disease (documented >50% occlusion in any coronary vessel)
• Cardiac-related angina pectoris (> 2 episodes in the past 3 months)
• Myocardial infarction with ischemia on ECG (i.e., new ST-elevation/depression of >1mm in contiguous leads), or positive cardiac enzymes (Ratio of CK-MB: Total CK > 3.5).
• Peripheral vascular disease (documented >50% occlusion in any peripheral vessel).
• Moderate or severe ischemic/non-ischemic cardiomyopathy (documented ejection fraction < 40%).
• Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior)
• Currently pregnant or breastfeeding.
• Currently taking tricyclic antidepressants, glycosides, ketamine, or vasopressors with ongoing evidence of myocardial ischemia.
• Known allergy to study drug.
Drug: Liothyronine Sodium (T3) (modified formulation)
ARDS, Human, Lung, Wet, Thyroid, Pulmonary Edema, Lung Inflammation