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Trial · NCT05931601

Registered outcomes20

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

ListOutcomeTime frameDescription
PrimaryThe primary outcome is the proportion of patients achieving either SBP >100 mmHg or MAP > 65 mmHg or a target blood pressure set by the treating physician at 90 (±15) minutes after inclusion.At 90 minutesBed-side assessment during treatment and registered in the case report form.
SecondaryNumber of intensive care unit (ICU) free days alive within 30 daysAt 30 daysData is extracted from the Danish national registries or the patient's electronic medical record. Note: Death will count as 0 days.
SecondaryTime without shock within 24 hoursAt 24 hoursBed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
Secondary30-day all-cause mortalityAt 30 daysData is extracted from the Danish national registries or the patient's electronic medical records.
SecondaryIn-hospital all-cause mortalityAt hospital discharge, an average of 30 days efter inclusionData is extracted from the Danish national registries or the patient's electronic medical records.
OtherProportion of patients receiving vasopressor at any point within 24 hoursAt 24 hoursBed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
OtherTime to vasopressor initiationAt 30 daysBed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
OtherHours of vasopressor infusionAt 30 daysBed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
OtherProportion of patients with pulmonary oedema within 72 hoursAt 72 hoursBed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
OtherProportion of patients with acute kidney failure within 72 hoursAt 72 hoursBed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
OtherNumber of organ support free days alive within 30 daysAt 30 daysOrgan support is defined as either mechanical ventilation, vasopressor/inotrope therapy or dialsysis. Data is extracted from the Danish national registries or the patient's electronic medical record.
OtherNumber of organ support free days alive within 30 daysAt 30 days
Organ support is defined as either mechanical ventilation, vasopressor/intotropic therapy or dialysis. Note: Death will count as 0 days. Data is extracted from the Danish national registries or the patient's electronic medical record.
OtherProportion of patients admitted to the ICUAt 30 daysData is extracted from the patient's electronic medical records.
OtherED Length of stayAt 72 hoursData is extracted from the patient's electronic medical records.
OtherICU length of stayAt 30 daysData is extracted from the patient's electronic medical records.
OtherHospital length of stayAt 30 daysData is extracted from the patient's electronic medical records.
OtherProportion and duration of mechanical ventilationAt 30 daysData is extracted from the patient's electronic medical records.
OtherProportion and length of renal replacement therapyAt 30 daysData is extracted from the patient's electronic medical records.
OtherAmount of fluid therapy within the first 24 hoursAt 24 hoursBed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.
Other
Proportion of serious adverse events for noradrenaline or fluid therapy, e.g. extravasation or overdosis of noradrenaline, pulmonary edema, new cardiac arrhytmias, during the intervention of control period
At 24 hoursBed-side assessment during treatment and registered in the case report form or by extraction from the patient's electronic medical record.

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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