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NCT04115514 · ClinicalTrials.gov registry record · Phase 2
Treatment of ARDS With Instilled T3
A Phase 2 study of Thyroid and Pulmonary Edema, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 2
- Study locations
NCT04115514: Recruiting Phase 2 study of Thyroid and Pulmonary Edema, sponsored by University of Minnesota.
NCT04115514 is a Phase 2 study of Thyroid and Pulmonary Edema that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 68 participants, below the 331-participant average among 5 other Thyroid trials with a reported enrollment target (79% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04115514, a Phase 2 study of Thyroid and Pulmonary Edema, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 2
- Study locations
Study 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).
Primary Outcome
To assess the efficacy of airway instilled T3 improving oxygenation by reducing OI and OSI in ARDS patients. OI will be measured by mechanical ventilator (FIO2 and Mean Airway Pressure, MAP), and ABG (PaO2). OSI will be measured by mechanical ventilator (FIO2, SpO2 and MAP): OI = (FIO2 x MAP / PaO2). OSI = (FIO2 x MAP / SpO2).
Conditions Studied
Interventions
- DRUG Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.
- OTHER Non-intervention
Study Locations (2)
Minnesota
- M Health Fairview Southdale Hospital - Edina
- East Bank Hospital - M Health Fairview University of Minnesota Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2020-03-30 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What NCT04115514 shows while recruiting
NCT04115514 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 331-participant average among 5 other Thyroid trials with a reported enrollment target (79% lower).
The record links to 5 conditions, with Thyroid appearing as the primary indexed condition, and to 2 interventions - of which Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation. is the first listed.
NCT04115514 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT04115514 about?
NCT04115514 is a clinical study titled "Treatment of ARDS With Instilled T3". 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).
What is the current status of trial NCT04115514?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2020-03-30. Estimated completion is 2026-10-31.
What conditions does trial NCT04115514 study?
This clinical trial studies the following conditions: Thyroid, Pulmonary Edema, Lung Inflammation, ARDS, Human, Lung, Wet.
What interventions are being tested in trial NCT04115514?
The interventions under investigation include: Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation. (DRUG), Non-intervention (OTHER).
Who is sponsoring clinical trial NCT04115514?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04115514 being conducted?
This trial has 2 study locations across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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