Trial · NCT04115514
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 26
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). | baseline | 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). |
| Primary | Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). | 6 hours post-dose | 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). |
| Primary | Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). | 12 hours post-dose | 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). |
| Primary | Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). | 24 hours post-dose | 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). |
| Primary | Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). | 48 hours post-dose | 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). |
| Primary | Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). | 72 hours post-dose | 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). |
| Primary | Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). | 96 hours post-dose | 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). |
| Primary | Oxygenation: Oxygenation Index (OI), and/or Oxygenation Saturation Index (OSI). | 120 hours post-dose | 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). |
| Secondary | Pulmonary events | baseline and 120 hours post-dose | 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. |
| Secondary | Cardiovascular event 1 | baseline to 120hours post-dose | New sustained ventricular arrhythmia (\>30 secs) |
| Secondary | Cardiovascular event 2 | baseline to 120hours post-dose | New sustained accelerated junctional arrhythmia (rate \>80 bpm) with worsened hypotension (decrease in mean arterial pressure to less than 65mmHg). |
| Secondary | Cardiovascular event 3 | baseline to 120hours post-dose | New sustained atrial fibrillation with rapid ventricular response (ventricular rate \>160 bpm) with worsened hypotension (decrease in mean arterial pressure to less than 65mmHg). |
| Secondary | Cardiovascular event 4 | baseline to 120hours post-dose | Cardiac arrest (pulseless electrical activity, or asystole). |
| Secondary | Cardiovascular event 5 | baseline to 120hours post-dose | 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). |
| Secondary | SOC pulmonary vasodilator | baseline and 5 days | yes or no |
| 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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