Treatment of ARDS With Instilled T3

Last updated: October 23, 2024
Sponsor: University of Minnesota
Overall Status: Active - Recruiting

Phase

2

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

NCT04115514
PACS-2020-23242
  • Ages > 18
  • All Genders

Study Summary

It is hypothesized that instillation of Liothyronine Sodium (T3) into the airspace will be safe, well tolerated, and will increase alveolar fluid clearance and decrease inflammation in patients with ARDS, reflected in improved oxygenation index (OI) and oxygenation saturation index (OSI).

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):

  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 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:

  1. Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120mmHg),

  2. Sustained ventricular arrhythmia in the past 3 months (duration >30 seconds)

  3. Coronary artery disease (documented >=70% occlusion untreated in any coronaryvessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary ArteryRevascularization.

  4. Cardiac-related angina pectoris (>=2 episodes in the past 3 months)

  5. Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depressionof >1mm in contiguous leads).

  6. 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.

  7. 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

Total Participants: 68
Treatment Group(s): 3
Primary Treatment: Liothyronine Sodium (T3) (modified formulation)
Phase: 2
Study Start date:
October 21, 2019
Estimated Completion Date:
October 31, 2025

Study Description

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.

Connect with a study center

  • Essentia Health - St. Mary's Medical Center

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • M Health Fairview Southdale Hospital

    Edina, Minnesota 55435
    United States

    Active - Recruiting

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

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • M Health Fairview Bethesda Hospital

    Saint Paul, Minnesota 55103
    United States

    Active - Recruiting

  • M Health Fairview St. Joseph's Hospital

    Saint Paul, Minnesota 55102
    United States

    Site Not Available

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