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Trial · NCT03338569

Registered outcomes12

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

ListOutcomeTime frameDescription
PrimaryNumber of Participants With ICU Mortality28 daysOutcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).
PrimaryAll Cause Mortality at 28 Days28 daysOutcome is reported as the number of participants who have expired at 28 days post intervention
SecondaryDuration of Vasopressor Therapy28 daysOutcome is reported as the duration in hours of vasopressor therapy post intervention administration
SecondaryDuration of ICU Stay Post Intervention Administration28 daysOutcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration
SecondaryTime to Lactate Clearance Post Intervention Administration28 days
SecondaryRate of Lactate Clearance Post Intervention Administration24, 48, 72, and 96 hours post intervention
Outcome is reported as the number of participants who clear lactate from the bloodstream at 24, 48, 72, and 96 hours post intervention. Clearance is defined as a serum concentration of 2.0 mmol/l or less.
SecondaryRate of Procalcitonin Clearance Post Intervention Administration4 days
SecondaryNumber of Participants With Need for Renal Replacement Therapy4 daysOutcome is reported as the number of participants who require renal replacement therapy
SecondaryChange in Serum CreatinineBaseline and 4 daysOutcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl.
SecondaryChange in Sequential Organ Failure Assessment (SOFA) ScoreBaseline and 4 daysSOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems. Total scores range from 0 to 24, with higher scores indicating higher likely mortality.
SecondaryChange in Acute Physiology and Chronic Health Evaluation (APACHE) ScoresBaseline and 4 days
APACHE score is a severity-of-disease classification system that is calculated from a patient's age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death.
SecondaryTotal Intravenous Fluid Administered24 hoursOutcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment.

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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