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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04115514
Other study ID # 036127
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 21, 2019
Est. completion date October 31, 2024

Study information

Verified date October 2023
Source University of Minnesota
Contact Melissa Rhodes
Email frak0001@umn.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 68
Est. completion date October 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Study population is critically ill patients requiring mechanical ventilatory support for ARDS in an intensive care unit. - Adults (=18 years of age). - Male or female (non-pregnant). - Clinical diagnosis of ARDS (all are required): 1. Onset: <= 7 days. 2. Chest x-ray: Bilateral Patchy Opacities, Infiltrates. 3. Mechanical Vent Support: PEEP or CPAP Support >= 5 cm H2O. 4. Pulmonary Edema: Not fully explained by cardiogenic etiology. 5. Hypoxia: PaO2/FIO2 Ratio <300, or O2Sat/FIO2 Ratio <315. - On mechanical ventilatory support. - Capable of giving informed consent directly or from the subject's legally authorized representative (LAR) as determined by the site Principal Investigator and/or Sub- Investigators. Exclusion Criteria: Patients with any of the following conditions will be excluded from this trial: - Inadequate medical history for determining inclusion/exclusion criteria, as determined by the Principal Investigator and/or Sub- Investigators. - Unlikely to complete the protocol with clinic follow-up after discharge, as determined by the Principal Investigator and/or Sub- Investigators or hospice status. - Prior history of thyroid cancer or hyperthyroidism, per thorough patient/family interviews, review of past medical history, medication list, laboratory test. - Prior history of cardiovascular disease defined as: 1. Hypertensive crisis in the past 3 months (systolic >200, or diastolic >120 mmHg), 2. Sustained ventricular arrhythmia in the past 3 months (duration >30 seconds) 3. Coronary artery disease (documented >=70% occlusion untreated in any coronary vessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization. 4. Cardiac-related angina pectoris (>=2 episodes in the past 3 months) 5. Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depression of >1mm in contiguous leads). 6. Peripheral vascular disease (documented >=70% occlusion untreated in any peripheral vessel), as per the 2018 ACC/AHA/SCAI/SIR/SVM Guidelines for Appropriate Use Criteria for Peripheral Artery Intervention. 7. Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior) - Currently pregnant or breastfeeding. - Known allergy to study drug.

Study Design


Intervention

Drug:
Liothyronine Sodium (T3+0.9% sodium chloride) modified formulation specifically for airway instillation.
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.
Other:
Non-intervention
Standard of Care (SOC)

Locations

Country Name City State
United States M Health Fairview Southdale Hospital Edina Minnesota
United States East Bank Hospital - M Health Fairview University of Minnesota Medical Center Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
baseline
Primary 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).
6 hours post-dose
Primary 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).
12 hours post-dose
Primary 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).
24 hours post-dose
Primary 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).
48 hours post-dose
Primary 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).
72 hours post-dose
Primary 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).
96 hours post-dose
Primary 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).
120 hours post-dose
Secondary 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. baseline and 120 hours post-dose
Secondary Cardiovascular event 1 New sustained ventricular arrhythmia (>30 secs) baseline to 120hours post-dose
Secondary Cardiovascular event 2 New sustained accelerated junctional arrhythmia (rate >80 bpm) with worsened hypotension (decrease in mean arterial pressure to less than 65mmHg). baseline to 120hours post-dose
Secondary 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). baseline to 120hours post-dose
Secondary Cardiovascular event 4 Cardiac arrest (pulseless electrical activity, or asystole). baseline to 120hours post-dose
Secondary 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). baseline to 120hours post-dose
Secondary SOC pulmonary vasodilator yes or no baseline and 5 days
Secondary SOC pressor(s) dose(s) baseline and 5 days
Secondary SOC diurectic(s) dose(s) baseline and 5 days
Secondary Ventilator Free Days baseline and 5 days
Secondary ICU Free Days baseline and 5 days
Secondary Oxygen Free Days baseline and 5 days
Secondary All-Cause Mortality baseline and 5 days
Secondary Tracheostomy placement requirement baseline and 5 days
Secondary Supplemental oxygen on discharge yes or no baseline and 5 days
Secondary Discharge disposition home, inpatient rehabilitation, long-term acute care hospital (LTACH) baseline and 5 days
Secondary TSH, Total T3, Free T3, Free T4 baseline and 156-hrs post-dose
Secondary Free T3, Free T4 baseline and 5 days
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