Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/3/2019 |
| Start Date: | June 2012 |
| End Date: | December 19, 2018 |
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.
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.
This study is a multi-institutional 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
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
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.
We found this trial at
2
sites
Atlanta, Georgia 30322
Principal Investigator: Bahaaldin Alsoufi, MD
Phone: 404-785-1731
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Charleston, South Carolina
Phone: 843-792-3287
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