Recruiting

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)

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What is being tested

Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.

+ Non-intervention

DrugOther
Who is being recruted

Endocrine System Diseases+7

+ Infections

+ Lung Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2020
See protocol details

Summary

Principal SponsorUniversity of Minnesota
Study ContactMelissa Rhodes
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitlePHASE 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)
NCT04115514
Principal SponsorUniversity of Minnesota
Study ContactMelissa Rhodes
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Endocrine System DiseasesInfectionsLung DiseasesPneumoniaPulmonary EdemaRespiration DisordersRespiratory Distress SyndromeRespiratory Tract DiseasesRespiratory Tract InfectionsThyroid Diseases

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.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.

Group II

Standard of Care

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

Recruiting

M Health Fairview Southdale Hospital

Edina, United StatesOpen M Health Fairview Southdale Hospital in Google Maps
Recruiting

East Bank Hospital - M Health Fairview University of Minnesota Medical Center

Minneapolis, United States
Recruiting
2 Study Centers