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Trial · NCT07569536

Registered outcomes15

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

ListOutcomeTime frameDescription
Primary30-day mortalityDay 30 after randomizationVital status at day 30 after randomization.
Secondary72-hour mortality72 hours after randomizationVital status at 72 hours after randomization
SecondaryVasopressor exposure6, 12 and 24 hours after randomizationCumulative vasopressor dose and peak vasopressor dose expressed as norepinephrine-equivalent dose (NEE score)
SecondaryUse of vasopressin or recue therapiesFrom randomization to day 30Proportion of patients requiring vasopressin or any therapy for refractory shock during follow-up
SecondaryMean arterial pressure (MAP)Baseline, 6 hours, 12 hours and 24 hours after randomizationEvolution of mean arterial pressure (MAP) and MAP to norepinephrine-equivalent (Neq) dose ration (MAP/Neq) to assess vasopressor responsiveness
SecondaryVasopressor-free daysDay 0 to day 30Number of days without vasopressor therapy during the first 30 days following randomization
SecondaryMechanical ventilation-free daysDay 0 to day 30Number of days without mechanical ventilation during the first 30 days following randomization
SecondaryBlood lactate concentration6 hours, 12 hours and 24 hours after randomizationArterial blood lactate levels
SecondarySOFA scoreBaseline and day 3 after randomizationEvolution of organ failure assessed using the Sequential Organ Failure Assessment (SOFA) score (minimum 0, maximum 24).
SecondaryCumulative fluid balanceDay 0 to day 5Difference between total fluid intake and total fluid output
SecondaryNew-onset or persistent atrial fibrillationWithin 14 days after randomizationOccurrence of new-onset atrial fibrillation or persistence of atrial fibrillation requiring clinical management.
SecondaryICU and 90-day mortalityAt day 3 and day 90 after randomizationVital status at Intensive Care Unit (ICU) discharge and at 90 days following randomization.
SecondaryClinically significant bradycardiaDuring the treatment period (until day 30)Occurrence of bradycardia defined as heart rate \< 50 bpm requiring therapeutic intervention
SecondaryComa-free daysDay 0 to day 30 or ICU dischargeNumber of days without coma up to day 30
SecondaryICU deliriumDaily until day 30 or ICU dischargeOccurrence of delirium during ICU stay assessed daily using the CAP-ICU in patients with RASS≥ -3

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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