Phase
Condition
Inflammation
Pneumonia
Lung Injury
Treatment
Liothyronine Sodium (T3) (modified formulation)
Non-intervention
Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 authorizedrepresentative (LAR) as determined by the site Principal Investigator and/or Sub-Investigators.
Exclusion
Exclusion Criteria:
Patients with any of the following conditions will be excluded from this trial:
Inadequate medical history for determining inclusion/exclusion criteria, asdetermined by the Principal Investigator and/or Sub- Investigators.
Unlikely to complete the protocol with clinic follow-up after discharge, asdetermined by the Principal Investigator and/or Sub- Investigators or hospicestatus.
Prior history of thyroid cancer or hyperthyroidism, per thorough patient/familyinterviews, review of past medical history, medication list, laboratory test.
Prior history of cardiovascular disease defined as:
Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120mmHg),
Sustained ventricular arrhythmia in the past 3 months (duration >30 seconds)
Coronary artery disease (documented >=70% occlusion untreated in any coronaryvessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary ArteryRevascularization.
Cardiac-related angina pectoris (>=2 episodes in the past 3 months)
Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depressionof >1mm in contiguous leads).
Peripheral vascular disease (documented >=70% occlusion untreated in anyperipheral vessel), as per the 2018 ACC/AHA/SCAI/SIR/SVM Guidelines forAppropriate Use Criteria for Peripheral Artery Intervention.
Decompensated or symptomatic heart failure (i.e., hospitalized for CHFexacerbation, or a change in CHF medications within two weeks prior)
Currently pregnant or breastfeeding.
Known allergy to study drug.
Study Design
Study Description
Connect with a study center
Essentia Health - St. Mary's Medical Center
Duluth, Minnesota 55805
United StatesSite Not Available
M Health Fairview Southdale Hospital
Edina, Minnesota 55435
United StatesActive - Recruiting
East Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United StatesActive - Recruiting
M Health Fairview Bethesda Hospital
Saint Paul, Minnesota 55103
United StatesActive - Recruiting
M Health Fairview St. Joseph's Hospital
Saint Paul, Minnesota 55102
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.