View Clinical Trial (Medical Research Study)
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
| City: |
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Charleston |
| State: |
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South Carolina |
| Zip Code: |
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29425 |
| Conditions: |
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Congenital Heart Disease - Disorder of Fetus or Newborn |
| Purpose: |
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Although cardiopulmonary bypass (heart-lung machine) is a necessary component of heart
surgery, it is not without consequences. Cardiopulmonary bypass initiates a potent
inflammatory response secondary to the body's recognition of the abnormal environment of the
heart-lung machine. This inflammatory response may lead to poor heart, lung and kidney
function after the heart surgery. This is turn can lead to longer times on the ventilator
(breathing machine), the need for higher doses of heart medications, a longer stay in the
intensive care unit and even death. This is particularly true in infants less than one
month of age due to their size and the immaturity of their organs. The appreciation of the
post-cardiopulmonary bypass inflammatory response has resulted in a number of interventions
directed at its reduction. No therapy has been recognized as the standard of care; however
steroid therapy has been applied most often despite unclear evidence of a benefit. This
study aims to determine if steroids improve the outcomes of babies undergoing heart surgery.
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| Study Summary: |
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This study is a randomized double-blind placebo controlled trial of the use of
glucocorticoids to improve the clinical course of neonates following cardiac surgery.
Cardiopulmonary bypass (CPB) is critical to cardiac surgery, but the pathophysiologic
processes engendered by CPB play an important role in post-operative recovery. The use,
doses and schedule of glucocortiocoid administration to ameliorate these CPB induced
processes is highly variable and without clear data to provide direction. The Primary Aim of
this study is to compare the effects of intraoperative methylprednisolone to placebo on a
composite morbidity-mortality outcome following neonatal CPB. Secondary Endpoints include:
inotropic requirements, incidence of low cardiac output syndrome, fluid balance, ICU stay
parameters, levels of inflammatory molecules, neuro-developmental outcomes, and safety
parameters. The study will focus on neonates because their post-CPB clinical course is
typically more severe, and that 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
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| Criteria: |
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Inclusion Criteria:
- Age < 1 month
- Male and female patients who are scheduled to undergo cardiac surgery involving CPB
Exclusion Criteria:
- Prematurity: < 37 weeks post gestational age at time of surgery
- Treatment with intravenous steroids within the two days 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 (eg - gastrointestinal bleeding).
- Preoperative use of mechanical circulatory support or active resuscitation at the
time of proposed randomization.
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| NCT ID: |
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NCT01579513 |
| Primary Contact: |
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Principal Investigator
Eric M Graham, MD
Medical University of South Carolina
Eric M Graham, MD
Phone: 843-792-8704
Email: grahamem@musc.edu
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| Backup Contact: |
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Email: infingep@musc.edu
Patricia G Infinger
Phone: 843-792-7857
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| Location Contact: |
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Charleston, South Carolina 29425
United States
Eric M Graham, MD
Phone: 843-792-8704
Email: grahamem@musc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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