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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
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.
Standard of Care (SOC)
M Health Fairview Southdale Hospital
Edina, Minnesota, United States
RECRUITINGEast Bank Hospital - M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota, United States
RECRUITINGOxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
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).
Time frame: baseline
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
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).
Time frame: 6 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
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).
Time frame: 12 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
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).
Time frame: 24 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
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).
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Time frame: 48 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
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).
Time frame: 72 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
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).
Time frame: 96 hours post-dose
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
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).
Time frame: 120 hours post-dose
Pulmonary events
Progressive hemoptysis: bright, red blood in streaks, mixed or clots within sputum on suctioning of greater than 30 mL accumulation anytime following the initial and subsequent intratracheal dosing administrations.
Time frame: baseline and 120 hours post-dose
Cardiovascular event 1
New sustained ventricular arrhythmia (\>30 secs)
Time frame: baseline to 120hours post-dose
Cardiovascular event 2
New sustained accelerated junctional arrhythmia (rate \>80 bpm) with worsened hypotension (decrease in mean arterial pressure to less than 65mmHg).
Time frame: baseline to 120hours post-dose
Cardiovascular event 3
New sustained atrial fibrillation with rapid ventricular response (ventricular rate \>160 bpm) with worsened hypotension (decrease in mean arterial pressure to less than 65mmHg).
Time frame: baseline to 120hours post-dose
Cardiovascular event 4
Cardiac arrest (pulseless electrical activity, or asystole).
Time frame: baseline to 120hours post-dose
Cardiovascular event 5
Hypertensive crisis (systolic pressure of 180 mmHg (or higher), or diastolic pressure of 120 mmHg (or higher) or change in MAP \> 20 mmHg with three consecutive measurements over 30 minutes).
Time frame: baseline to 120hours post-dose
SOC pulmonary vasodilator
yes or no
Time frame: baseline and 5 days
SOC pressor(s) dose(s)
Time frame: baseline and 5 days
SOC diurectic(s) dose(s)
Time frame: baseline and 5 days
Ventilator Free Days
Time frame: baseline and 5 days
ICU Free Days
Time frame: baseline and 5 days
Oxygen Free Days
Time frame: baseline and 5 days
All-Cause Mortality
Time frame: baseline and 5 days
Tracheostomy placement requirement
Time frame: baseline and 5 days
Supplemental oxygen on discharge
yes or no
Time frame: baseline and 5 days
Discharge disposition
home, inpatient rehabilitation, long-term acute care hospital (LTACH)
Time frame: baseline and 5 days
TSH, Total T3, Free T3, Free T4
Time frame: baseline and 156-hrs post-dose
Free T3, Free T4
Time frame: baseline and 5 days