ARDS+T3PHASE 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)
Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.
+ Non-intervention
Endocrine System Diseases+7
+ Infections
+ Lung Diseases
Treatment Study
Summary
Study start date: March 30, 2020
Actual date on which the first participant was enrolled.T3 Therapy in ARDS- Phase 2 Randomized, Unblinded, Intervention versus Non- Intervention Trial. Enrollment 68 participants (50 treatment + 18 control). Purpose- To determine the safety and tolerability of T3 delivery into the lungs of ARDS patients, and to measure the effect of T3 on Oxygenation in ARDS patients. Study Drug- Liothyronine Sodium (T3), 50 mcg will be instilled twice daily via a catheter through the ETT into the airway in a total volume of 10 mL (T3+0.9% sodium chloride), over 5 days (10 total doses), or until extubation, whichever comes first.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.68 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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): 1. Onset: \<= 7 days. 2. Chest x-ray: Bilateral Patchy Opacities, Infiltrates. 3. Mechanical Vent Support: PEEP or CPAP Support \>= 5 cm H2O. 4. Pulmonary Edema: Not fully explained by cardiogenic etiology. 5. 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. Exclusion Criteria: Patients with any of the following conditions will be excluded from this trial: * 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. * 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 defined as: 1. Hypertensive crisis in the past 3 months (systolic \>200, or diastolic \>120 mmHg), 2. Sustained ventricular arrhythmia in the past 3 months (duration \>30 seconds) 3. Coronary artery disease (documented \>=70% occlusion untreated in any coronary vessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization. 4. Cardiac-related angina pectoris (\>=2 episodes in the past 3 months) 5. Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depression of \>1mm in contiguous leads). 6. Peripheral vascular disease (documented \>=70% occlusion untreated in any peripheral vessel), as per the 2018 ACC/AHA/SCAI/SIR/SVM Guidelines for Appropriate Use Criteria for Peripheral Artery Intervention. 7. 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. * Known allergy to study drug.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
M Health Fairview Southdale Hospital
Edina, United StatesOpen M Health Fairview Southdale Hospital in Google MapsEast Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, United States