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Thyroid Hormone

T3 Instillation for Acute Respiratory Distress Syndrome (ARDS+T3 Trial)

Phase 2
Recruiting
Led By Timothy P Rich, MD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults (≥18 years of age).
Study population is critically ill patients requiring mechanical ventilatory support for ARDS in an intensive care unit.
Must not have
Prior history of cardiovascular disease with specific conditions including hypertensive crisis, sustained ventricular arrhythmia, coronary artery disease, cardiac-related angina pectoris, myocardial infarction, peripheral vascular disease, decompensated or symptomatic heart failure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 hours post-dose
Awards & highlights

Summary

This trial is testing whether putting a hormone called T3 into the lungs will help clear out fluid and reduce extravascular lung water, which is a marker of severity in ARDS.

Who is the study for?
This trial is for adults over 18 with ARDS needing ventilators in ICU. They must be able to consent or have a representative who can, and not be pregnant or breastfeeding. Excluded are those allergic to the drug, with thyroid cancer, hyperthyroidism, significant heart disease, or unlikely to follow the study through.
What is being tested?
The trial tests if Liothyronine Sodium (T3), instilled directly into the lungs of ARDS patients, is safe and effective at improving lung function by increasing fluid clearance and reducing inflammation as measured by oxygenation levels.
What are the potential side effects?
Potential side effects may include reactions related to thyroid hormone imbalance such as palpitations, sweating, restlessness; however specific side effects from direct lung instillation are being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
I am in the ICU and need a machine to help me breathe due to severe lung injury.
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I have been diagnosed with ARDS and require a ventilator to help me breathe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of serious heart conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Secondary study objectives
Cardiovascular event 1
Cardiovascular event 2
Cardiovascular event 3
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.
Group II: Control armExperimental Treatment1 Intervention
Standard of Care

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,413 Previous Clinical Trials
1,561,335 Total Patients Enrolled
Timothy P Rich, MDPrincipal InvestigatorUniversity of Minnesota
1 Previous Clinical Trials
250 Total Patients Enrolled
David H Ingbar, MDStudy ChairUniversity of Minnesota

Media Library

Liothyronine Sodium (T3) (Thyroid Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT04115514 — Phase 2
Pulmonary Edema Research Study Groups: Treatment Arm, Control arm
Pulmonary Edema Clinical Trial 2023: Liothyronine Sodium (T3) Highlights & Side Effects. Trial Name: NCT04115514 — Phase 2
Liothyronine Sodium (T3) (Thyroid Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04115514 — Phase 2
~1 spots leftby Oct 2024
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