Could a thyroid hormone boost oxygen in severe lung failure?
NCT ID NCT04115514
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a thyroid hormone (T3) directly into the lungs can safely improve oxygen levels in adults with acute respiratory distress syndrome (ARDS), a severe lung condition. About 68 critically ill patients on ventilators will either receive the hormone or standard care. The goal is to see if T3 helps clear fluid and reduce inflammation in the lungs.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 68 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2020
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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East Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
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M Health Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
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