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Trial · NCT00543309

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryDays Alive and Out of the Hospital Within 30 Days of Surgery.30 days
SecondaryCardiovascular: Cardiac IndexPostoperative hour #1Cardiac index measured using Fick principle with measured oxygen consumption.
SecondaryCardiovascular: Cardiac IndexPostoperative hour #8Cardiac index measured using Fick principle with measured oxygen consumption.
SecondaryCardiovascular: ArrhythmiaPostoperative day (POD) #0 through 5arrhythmia lasting \>30 seconds or requiring treatment
SecondaryCardiovascular: Peak Inotrope ScoreInitial 24 hours in CICU
Peak Inotrope Score = Doses of dopamine in mcg/kg/minute + dobutamine in mcg/kg/minute + (epinephrine in mcg/kg/minute x 100). The lowest (best) possible Peak Inotrope Score = 0 dose equivalents. There is no maximum Peak Inotrope Score.
SecondaryCardiovascular: Peak Lactate LevelInitial 24 hours in CICU
SecondaryRenal Function: Urine Outputfirst 24 hours CICU admitVolume of urine in mL/kg per day
SecondaryRenal Function: Maximum Change in Serum Creatinine14 days after surgery
SecondaryResource Utilization: Hours of Mechanical Ventilation Until Initial ExtubationFrom Fontan operation until initial extubation, assessed during initial CICU stay, up to 30 days.Hours of mechanical ventilation until initial extubation following the Fontan operation.
SecondaryResource Utilization: Days of Initial CICU StayFrom Fontan operation until initial discharge from the CICU, assessed during the postoperative hospitalization, up to 90 days.Days of initial postoperative CICU care following the Fontan operation.
SecondaryResource Utilization: Chest Tube DaysFrom Fontan operation until final chest tube removed, assessed during postoperative hospitalization, up to 90 days.Days during which one or more chest tubes were in place following the Fontan operation.
SecondaryResource Utilization: Days Alive and Out of Hospital Within 180 Days of Surgery180 daysDays the patient was alive and out of hospital within the 180 days after Fontan surgery
SecondaryPlasma Norepinephrine Levels.Preoperative baseline to 24 hours after CICU admissionPlasma norepinephrine levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.
SecondaryEpinephrine LevelsPreoperative baseline to 24 hours after CICU admissionPlasma epinephrine levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.
SecondaryN-terminal Pro-brain Natriuretic Peptide LevelsPreoperative baseline to 24 hours after CICU admissionN-terminal pro-brain natriuretic peptide levels measured at preoperative baseline and postoperative CICU hour 1, 8, 24.

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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