Treatment of ARDS With Instilled T3

NCT ID: NCT04115514

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-30
• Study Completion Date: 2026-10-31

Brief 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).

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Study Drug Administration:

• Dose/Volume- Liothyronine Sodium 50 mcg / 10 mL
• Frequency/Duration: Twice daily over 5 days (10 total doses), or until extubation, whichever comes first.
• Method: Instilled via a catheter through the ETT directly into the airway.

Control arm

Standard of Care

Group Type: OTHER

Non-intervention

Intervention Type: OTHER

Standard of Care (SOC)

Interventions

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

Study Drug Administration:

• Dose/Volume- Liothyronine Sodium 50 mcg / 10 mL
• Frequency/Duration: Twice daily over 5 days (10 total doses), or until extubation, whichever comes first.
• Method: Instilled via a catheter through the ETT directly into the airway.

Intervention Type: DRUG

Non-intervention

Standard of Care (SOC)

Intervention Type: OTHER

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:

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Timothy P Rich, MD

Role: STUDY_DIRECTOR

University of Minnesota

David H Ingbar, MD

Role: STUDY_CHAIR

University of Minnesota

Ronald A Reikoff, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

M Health Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status: RECRUITING

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

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melissa Rhodes

Role: CONTACT

frak0001@umn.edu

Facility Contacts

David Ingbar, MD

Role: primary

David Ingbar, MD

Role: primary

References

Flory CM, Norris BJ, Larson NA, Coicou LG, Koniar BL, Mysz MA, Rich TP, Ingbar DH, Schumacher RJ. A Preclinical Safety Study of Thyroid Hormone Instilled into the Lungs of Healthy Rats-an Investigational Therapy for ARDS. J Pharmacol Exp Ther. 2021 Jan;376(1):74-83. doi: 10.1124/jpet.120.000060. Epub 2020 Oct 30.

Reference Type: DERIVED

PMID: 33127750 (View on PubMed)

Other Identifiers

PACS-2020-23242

Identifier Type: -

Identifier Source: org_study_id