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Trial · NCT07343206

Registered outcomes11

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

ListOutcomeTime frameDescription
Primary28-day survivalFrom enrollment to 28 days after enrollmentSurvival at 28-day after enrollment. Telephone follow-up for patients who are discharged before 28 days.
SecondaryNumber of participants with shock control achievedFrom enrollment to 6 hours after enrollment
Shock control defined as mean arterial pressure greater than 65 mmHg combined with urine output greater than 0.5 milliliters per kilogram per hour OR lactate clearance greater than 10 percent within 6 hours
SecondaryDuration of intensive care unit stayFrom enrollment to hospital discharge or 90 days (whichever comes first)Days of intensive care unit stay
SecondaryDuration of hospital stayFrom enrollment to hospital discharge or 90 days (whichever comes first)Days of hospital stay
SecondaryDuration of mechanical ventilationFrom enrollment to hospital discharge or 90 days (whichever comes first)Days on mechanical ventilation, including endotracheal tube and tracheostomy
SecondaryDuration of renal replacement therapyFrom enrollment to hospital discharge or 90 days (whichever comes first)
Days requiring renal replacement therapy, including continuous renal replacement therapy, intermittent hemodialysis, and peritoneal dialysis, that is newly initiated during this admission. Maintaining chronic hemodialysis is excluded.
SecondaryDuration of vasopressor therapyFrom enrollment to hospital discharge or 90 days (whichever comes first)Days requiring vasopressor therapy
SecondaryTime to Achievement of Early Goal-Directed Therapy TargetsFrom study drug initiation until achievement of all EGDT targets or up to 6 hoursTime in hours to achieve ALL EGDT targets: MAP ≥65 mmHg, urine output ≥0.5 mL/kg/hr, lactate clearance ≥10%, and ScvO₂ ≥70% (when measured)
SecondaryCumulative Fluid Volume Administered
Multiple assessments at: - Before randomization (baseline) - 1 hour after study drug initiation - 6 hours after study drug initiation - 24 hours (Day 1) 48 hours (Day 2) 72 hours (Day 3) after study drug initiation
Total volume in milliliters of intravenous crystalloid and colloid fluids administered during first 24 hours and first 72 hours Time Frame: At 1 hour, 6 hours, 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3) after treatment initiation
SecondaryIncidence of Pulmonary EdemaFrom diagnosis until hospital discharge 90 days or deathNew-onset cardiogenic pulmonary edema or non-cardiogenic pulmonary edema
SecondaryTreatment-Related Adverse Events Including Cardiac ArrhythmiasFrom study drug initiation until hospital discharge or death, assessed 90 daysComposite outcome including new-onset arrhythmias (AF, AFL, SVT, VT, VF, AV block, bradycardia), limb/mesenteric ischemia, skin necrosis, and severe hypertension

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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