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Trial · NCT06478797

Registered outcomes19

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

ListOutcomeTime frameDescription
PrimarySurvival free of organ support at 28 daysFrom time of randomization until 28 days, if death occurs, time is set to 0 daysOrgan support will be defined as invasive ventilation support, cardiovascular organ support (inotropic or ECMO support), and renal replacement therapy
SecondaryRecuitment rates12 monthsSecondary feasibility outcome 1
SecondaryProportion of eligible randomised12 monthsOther feasibility 2
SecondaryProportion of eligible consented using perspective consent and consent to continue12 monthsOther feasibility 3
SecondaryTime to initiation of inotropes between the control and the early inotrope arm24 hoursOther feasibility 4
SecondaryAmount of fluid delivered (in mLs per kg) during the first 24 h between the control and the early inotrope arm24 hoursOther feasibility 5
SecondaryProtocol violations12 monthsOther feasibility 6. Percentage of patients not treated according to the assigned group.
SecondarySurvival free of inotrope support at 7 days7 daysSecondary exploratory clinical outcome 1
SecondarySurvival free of invasive ventilation support at 7 days7 daysSecondary exploratory clinical outcome 2
Secondary28-day mortalityFrom time of randomization until 28 daysSecondary exploratory clinical outcome 3
SecondarySurvival free of PICU censored at 28 days28 daysSecondary exploratory clinical outcome 4
SecondaryPICU length of stay28 daysSecondary exploratory clinical outcome 5
SecondaryHospital length of stay28 daysSecondary exploratory clinical outcome 6
SecondaryFunctional Status Score at 28 days28 daysSecondary exploratory clinical outcome 7
SecondaryModified Pediatric Overall Performance Category at 28 days28 daysSecondary exploratory clinical outcome 7
SecondaryAmount of fluid (mLs per kg) received during the first hour, and by 4, 12, and 24 hour post enrolment24 hoursSecondary exploratory clinical outcome 8
SecondaryProportion of patients with lactate <2 mmol/l at 6, 12, and 24 hours post enrolment24 hoursSecondary exploratory clinical outcome 9
SecondaryTime to reversal of tachycardia during the first 24 h24 hoursSecondary exploratory clinical outcome 10
SecondaryTime to shock reversal, defined as cessation of inotropes for at least 4 h censored at 28 days28 daysSecondary exploratory clinical outcome 11

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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GET https://conductscience.org/api/trials/v1/NCT06478797/registered