Clinical Trial: Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Brief Summary: Randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB).

Detailed Summary: This study proposes a randomized controlled trial of the use of glucocorticoids to improve the clinical course of neonates post-cardiopulmonary bypass (CPB). The study will focus on neonates for a few reasons. Although their post-CPB clinical course is typically more severe and intensive care unit (ICU) care more prolonged than older children, their modes of morbidity are also well characterized. Further, the high level of severity itself provides a substrate for identifying the positive effects of a particular therapy. Finally, a therapy identified as beneficial has the greatest potential for benefit in this vulnerable population. The well characterized scenario of low cardiac output syndrome (LCOS) will be used as the primary endpoint, while a variety of secondary endpoints will be related to the biochemical anti-inflammatory effects of therapy, ICU care and late neurological outcome.
Sponsor: Medical University of South Carolina

Current Primary Outcome: Primary Endpoint: Number of Participants With Low Cardiac Output Syndrome (LCOS) or Death at 36 Hours From Admission to the Intensive Care Unit (ICU) After Surgery. [ Time Frame: 36 hours ]

The presence of low cardiac output syndrome (LCOS) was defined by the same definition used in the PRIMACORP study (Hoffman TM.et.al. Circulation 2003 107:996-1002). Specifically, if there were clinical signs and symptoms of low cardiac output (e.g., tachycardia, oliguria, cold extremities, cardiac arrest, etc.) which required one or more of the following interventions: mechanical circulatory support, the escalation of existing pharmacological circulatory support to >100% over baseline, or the initiation of new pharmacological circulatory support.


Original Primary Outcome: Primary Endpoint: Incidence of death or LCOS at 36 hours from admission to the ICu after surgery. [ Time Frame: 36 hours ]

Current Secondary Outcome:

  • Inotropic Score [ Time Frame: over the first 36 hours after surgery ]
    The inotropic score was calculated by the equation using drug dosages in micrograms/kg/min, (dopamine+dobutamine) + (milrinonex10) + (epinephrinex100) and recorded hourly upon arrival to the ICUthrough 36 hours postoperatively. The highest score during this timeframe was recorded. This score converts dosages of commonly used inotropic medications into a score. The higher the score the more inotropic medications required. The minimum score would be zero indicating no inotropic medications were used. There is no maximum score.
  • Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery [ Time Frame: at 36 hours and 30 days ]
    Number of participants who died of any cause between 36 hours and 30 days following cardiac surgery
  • Urine Output [ Time Frame: over 36 hours ]
    Total urine output in mL over the first 36 hours after cardiac surgery
  • Total Intake/Output of Fluid [ Time Frame: over 36 hours ]
    Total amount of all fluids in and out during the first 36 hours postoperatively in mL.


Original Secondary Outcome:

  • Inotropic Score [ Time Frame: over the first 36 hours after surgery ]
  • Individual indices of death and LCOS [ Time Frame: at 36 hours and 30 days ]
  • Urine Output [ Time Frame: over 36 hours ]
  • Total Intake/Output of Fluid [ Time Frame: over 36 hours ]


Information By: Medical University of South Carolina

Dates:
Date Received: July 6, 2009
Date Started: March 2007
Date Completion:
Last Updated: November 7, 2011
Last Verified: September 2011