Treatment of ARDS With Instilled T3
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- ARDS, Human
- Lung Inflammation
- Lung, Wet
- Pulmonary Edema
- Thyroid
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized, unblinded, intervention versus non-intervention trial. 68 [50 treatment + 18 controls]Masking: None (Open Label)Masking Description: None applicablePrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Randomized, unblinded, intervention versus non-intervention trial Purpose: To determine the safety and tolerability of T3 delivery into the lungs of ARDS patients, and to measure the effect of T3 on EVLW index in ARDS patients. Liothyronine Sodium (T3), 5-10-25-50µg will be instilled via catheter th...
Randomized, unblinded, intervention versus non-intervention trial Purpose: To determine the safety and tolerability of T3 delivery into the lungs of ARDS patients, and to measure the effect of T3 on EVLW index in ARDS patients. Liothyronine Sodium (T3), 5-10-25-50µg will be instilled via catheter through ETT into the airways in a total volume of 10 ml (T3+0.9% sodium chloride) over 4 days (96 hours) with progressive dosing. 68 participants [50 treatment + 18 controls] will be investigated over 18 months or until target enrollment is achieved. No research intervention will occur with control subjects. Control subjects will receive standard of care.
Tracking Information
- NCT #
- NCT04115514
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Timothy P Rich, MD University of Minnesota Study Chair: David H Ingbar, MD University of Minnesota
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