Treatment of ARDS With Instilled T3

Description

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).

Conditions

ARDS, Human, Lung, Wet, Thyroid, Pulmonary Edema, Lung Inflammation

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Study Overview

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Study Details

Study overview

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).

PHASE 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)

Treatment of ARDS With Instilled T3

Condition
ARDS, Human
Intervention / Treatment

-

Contacts and Locations

Edina

M Health Fairview Southdale Hospital, Edina, Minnesota, United States, 55435

Minneapolis

East Bank Hospital - M Health Fairview University of Minnesota Medical Center, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Timothy P Rich, MD, STUDY_DIRECTOR, University of Minnesota

David H Ingbar, MD, STUDY_CHAIR, University of Minnesota

Ronald A Reikoff, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2025-10-31