Clinical trial NCT00934843: Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Official title: Preoperative Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Disorder of Fetus or Newborn
Keywords: Cardiopulmonary Bypass (CPB)
System Inflammatory Response
Low Cardiac Output Syndrome (LCOS) in Neonates
Methylprednisolone
Cardiopulmonary Bypass (CPB) in Neonates
Glucocorticoid Use in Neonatal Cardiac Surgery
Steroid
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2009-07-08
Enrollment: 77
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Neonates Age \</= 1 month
* Scheduled to undergo cardiac surgery involving Cardiopulmonary Bypass (CPB) (reparative or palliative procedures)
* Inpatient Status at MUSC a minimum of 8 hours prior to planned surgery

Exclusion Criteria:

* Prematurity: \</= 36 weeks post gestational age at time of surgery
* Treatment with steroids, other than inhaled forms, in the two weeks prior to scheduled surgery
* Participation in research studies involving the evaluation of investigational drugs within 30 days of randomization
* Suspected infection that would contraindicate steroid use (eg - Herpes)
* Known hypersensitivity to IVMP or one of its components or other contraindication to steroid therapy (e.g., gastrointestinal bleeding)
* Preoperative use of mechanical circulatory support or active resuscitation at the time of proposed randomization
* Inability to begin the pre-operative study drug at least 8 hours prior to surgery

Primary outcomes:
measure: 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.
timeFrame: 36 hours
Secondary outcomes:
measure: Inotropic Score
timeFrame: over the first 36 hours after surgery
measure: Number of Participants Who Died Between 36 Hours and 30 Days Following Cardiac Surgery
timeFrame: at 36 hours and 30 days
measure: Urine Output
timeFrame: over 36 hours
measure: Total Intake/Output of Fluid
timeFrame: over 36 hours
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Eric M Graham, MD
role: PRINCIPAL_INVESTIGATOR
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