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Trial · NCT04505592

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants Free of Respiratory Failure28 DaysThe number of patients free of respiratory failure defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation at 28 days
PrimaryNumber of Participants With Occurrences of Bleeding28 daysSafety as assessed by number of participants with occurrences of intracranial bleeding or major bleeding
SecondaryNumber of Participants With In-hospital Deaths at 14 Days14 daysNumber of patients who expired in the hospital within the first 14 days of their participation in the study
SecondaryNumber of Participants With Death at 28 Days28 daysNumber of participants who expired by 28 days/end of study
SecondaryNumber of Ventilator-free Days28 daysNumber of ventilator-free days in 28 days period
SecondaryNumber of Respiratory Failure-free Days28 days
Respiratory failure-free defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation. Number of respiratory failure-free days in 28 days period.
SecondaryNumber of Vasopressor-free Days28 daysNumber of vasopressor-free days over 28 days period
SecondaryNumber of Vasopressor Doses at 24 Hours24 hours and 72 hours
SecondaryP/F Ratio24 hours and 72 hours
The P/F ratio equals the arterial pO2 ("P") from the ABG divided by the FIO2 ("F") - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40). Ratio of arterial pO2 over fraction of inspired oxygen that the person is receiving. Normal P/F Ratio is ≥ 400. 300 to 200 is considered mild ARDS 200 to 100 is considered moderate ARDS Anything below 100 is considered severe ARDS.
SecondaryNumber of ICU-free Days28 daysNumber of days the patient spent outside the ICU
SecondaryHospital Length of Stayup to 29 daysLength of time the patient spent in the hospital, including ICU
SecondaryNumber of Participants With New-onset Renal Failure28 daysNumber of patients who experienced renal failure during the course of the study
SecondaryNumber of Participants With Need for Renal Replacement Therapy28 daysNumber of patients who underwent renal replacement treatment for their renal failure

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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