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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 156-hrs post-dose

Awards & highlights

ARDS+T3 Trial 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.Check my eligibility

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.See study design

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.

ARDS+T3 Trial 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.

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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.

ARDS+T3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 156-hrs post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 156-hrs post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 156-hrs post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).

Secondary outcome measures

All-Cause Mortality

Cardiovascular event 1

Cardiovascular event 2

+15 more

ARDS+T3 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,381 Previous Clinical Trials

1,588,707 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this investigation at the present moment?

"This clinical trial is currently accepting participants; the data was initially published on October 21st 2019 and edited for posterity on September 29th 2022."

Answered by AI

What is the participant limit for this research project?

"Affirmative. The clinicaltrials.gov database reveals that this research is presently recruiting patients and has been modified as recently as September 29th 2022. This trial requires 68 participants to be enrolled from 5 sites."

Answered by AI

In what locations can this clinical experiment be accessed?

"The trial is currently being held at 5 sites, including Saint Paul, Duluth and Minneapolis. With this in mind it's important to pick the most convenient location for you to avoid excessive travel requirements upon enrollment."

Answered by AI

To what ailment is Liothyronine Sodium (T3) (modified formulation) typically prescribed?

"Liothyronine Sodium (T3) (modified formulation) is frequently prescribed to treat thyroid cancer in addition to myxedema pre-coma, euthyroid goitre, and other supplemental or replacement therapies."

Answered by AI

What other research studies have explored the potential benefits of a modified formulation of Liothyronine Sodium (T3)?

"Currently, 4 clinical trials are ongoing to evaluate the efficacy of Liothyronine Sodium (T3) in a modified formulation. None of these investigations have advanced beyond Phase 3 yet and they all originated from Edina, Minnesota with 8 additional sites running experiments for this medication."

Answered by AI