Using T3 to treat ARDS

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)

This study is testing if giving a thyroid hormone directly into the lungs can help people with Acute Respiratory Distress Syndrome breathe better and reduce lung inflammation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Minnesota (Academic / other)
• Locations: 2 sites (Edina, Minnesota and 1 other locations)
• Trial ID: NCT04115514 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and tolerability of instilling Liothyronine Sodium (T3) directly into the lungs of patients with Acute Respiratory Distress Syndrome (ARDS). The study involves a randomized, unblinded approach with 68 participants, where 50 will receive the treatment and 18 will serve as controls. The primary goal is to assess the impact of T3 on improving oxygenation and reducing inflammation in the lungs. Participants will receive T3 twice daily via a catheter for up to five days or until extubation.

Who should consider this trial

Good fit: Ideal candidates are critically ill adults requiring mechanical ventilation for ARDS with specific clinical criteria.

Not a fit: Patients with ARDS not requiring mechanical ventilation or those with cardiogenic pulmonary edema may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve oxygenation and reduce lung inflammation in ARDS patients.

How similar studies have performed: While this approach is novel, similar studies exploring lung instillation therapies have shown promise in improving outcomes for respiratory conditions.

Eligibility 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.

Where this trial is running

Edina, Minnesota and 1 other locations

• M Health Fairview Southdale Hospital — Edina, Minnesota, United States (Recruiting)
• East Bank Hospital - M Health Fairview University of Minnesota Medical Center — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Ronald A Reikoff, MD — University of Minnesota
• Study coordinator: Melissa Rhodes

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