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Trial · NCT03640949

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants With Return of Spontaneous CirculationDuring the cardiac arrest, an average of 20 minutesReturn of spontaneous circulation is defined as spontaneous circulation with no further need for chest compressions sustained for at least 20 minutes
SecondaryNumber of Participants That Survived 30 DaysAt 30 days
SecondaryNumber of Participants With a Favorable Neurological Outcome at 30 DaysAt 30 days
A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.
OtherVasopressor-free Days7 daysVasopressor-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving vasopressors and is alive.
OtherInvasive Ventilation-free Days7 daysInvasive ventilation-free days will be defined as the number of days within the first 7 days after the cardiac arrest where the patient is not receiving invasive ventilation and is alive.
OtherSequential Organ Failure Assessment (SOFA) Score at 24, 48 and 72 Hours24, 48 and 72 hours
The SOFA score is a validated and widely used measure of organ failure assessing the respiratory, nervous, cardiovascular, hepatic, coagulation, and renal systems. We will assess both the cardiovascular sub score as well as the overall SOFA score.
OtherHospital DispositionAt hospital discharge, up to 1 yearHospital disposition (e.g. home, rehabilitation, nursing home, hospice) will be defined at the time of discharge from the initial acute care hospital.
OtherSurvivalAt 90 days, 180 days, and 1 year
OtherFavorable Neurological OutcomeAt 90 days, 180 days, and 1 year
A favorable neurological outcome will be defined as a cerebral performance category score of 1 or 2. The cerebral performance category score is a 5-point scale assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes.
OtherModified Rankin Scale (mRS)At 30 days, 90 days, 180 days, and 1 year
The mRS is a 7-point scale, ranging from 0 (no symptoms) to 6 (dead), assessing the degree of disability and dependence after a neurological injury such as stroke or cardiac arrest. A good outcome will be defined as a mRS of 0 to 3 and a poor outcome as 4 to 6.
OtherGlasgow Outcome Scale Extended (GOSE)At 30 days, 90 days, 180 days, and 1 year
The GOSE is a 8-point scale that is an extension of the Glasgow Outcomes Scale (which is identical to the CPC, only with inverse scores) where the scores 1, 2 and 3 from the CPC score is divided into two.
OtherHealth-related Quality of Life (EQ-5D-5L)At 30 days, 90 days, 180 days, and 1 yearThe EQ-5D-5L is a well-established measure of health-related quality of life that is quantified as a utility (i.e. a measure of quality of life between 0 and 1).

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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