Treatment of ARDS With Instilled T3 (NCT04115514) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Treatment of ARDS With Instilled T3
United States68 participantsStarted 2020-03-30
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Mechanical Vent Support: PEEP or CPAP Support \>= 5 cm H2O.
✓. Pulmonary Edema: Not fully explained by cardiogenic etiology.
✓. Hypoxia: PaO2/FIO2 Ratio \<300, or O2Sat/FIO2 Ratio \<315.
Exclusion criteria
✕. Hypertensive crisis in the past 3 months (systolic \>200, or diastolic \>120 mmHg),
✕. Sustained ventricular arrhythmia in the past 3 months (duration \>30 seconds)
✕. Coronary artery disease (documented \>=70% occlusion untreated in any coronary vessel), as per the 2021 ACC/AHA/SCAI Guidelines for Coronary Artery Revascularization.
✕. Cardiac-related angina pectoris (\>=2 episodes in the past 3 months)
✕. Myocardial infarction with ischemia on ECG (i.e.,new ST- elevation/depression of \>1mm in contiguous leads).
✕. 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.
✕. Decompensated or symptomatic heart failure (i.e., hospitalized for CHF exacerbation, or a change in CHF medications within two weeks prior)
What they're measuring
1
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Timeframe: baseline
2
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Timeframe: 6 hours post-dose
3
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Timeframe: 12 hours post-dose
4
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Timeframe: 24 hours post-dose
5
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Timeframe: 48 hours post-dose
6
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Timeframe: 72 hours post-dose
7
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).
Timeframe: 96 hours post-dose
8
Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI).