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Trial · NCT02170519

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryPercent Change in Oxygen Saturation (SpO2) From Baseline30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hoursReadings were taken from the medical record and the data may not have been present at the exact time frames.
PrimaryPercent Change in Oxygen Saturation (SpO2) From Baselinedose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
PrimaryChange in Mean Heart Rate From Baseline30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
PrimaryChange in Mean Heart Rate From Baselinedose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
PrimaryNumber of Treatment Failuresas long as subject was on drug up to approximately 24 hours
Treatment failure is defined as Central venous pressure (CVP) ≥ 20 mm Hg and any one of the following: 1. Cardiac Index (CI) \>/= 1.8 L/min/m2 2. Administration of \>/=0.1 ug/kg/min Epinephrine or Norepinephrine 3. MAP \</= 50 mmHg (or as appropriate for age in pediatrics). 4. SvO2\</= 55% (or \< 45% for patients with R to L intracardiac shunting and, thus, cyanosis at baseline.}
PrimaryChange in Mean Pulmonary Artery Pressure (mPAP) From Baseline30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
PrimaryChange in Mean Pulmonary Artery Pressure (mPAP) From Baselinedose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
SecondaryChange in Cardiac Output (CO) From Baseline30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hours
SecondaryChange in Cardiac Output (CO) From Baselinedose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)
SecondaryChange in Mean Venous Oxygen Saturation (SvO2) From Baseline30 mins after initial dose, every 2 hours as long as subject was on drug up to approximately 24 hoursSvO2 represents an average of all the venous oxygen saturations of the various organs and tissues.
SecondaryChange in Mean Venous Oxygen Saturation (SvO2) From Baselinedose 1 (1 hour), dose 2 (2 hour), dose 3 (3 hour), combined therapy (4.5 - 5 hour), end INO (6 - 7 hour)

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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