Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Congenital Heart Disease; Disorder of Fetus or Newborn

Treatments: Drug: Placebo; Drug: Methylprednisolone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01579513

R01HL112968 (U.S. NIH Grant/Contract)

Pro16545

Details and patient eligibility

About

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.

Full description

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

Enrollment: 190 patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups, including a placebo group

Intraoperative Methylprednisone

Active Comparator group

Description:

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass(CPB) in the first month of life that receive one dose of intravenous methylprednisolone (30 mg/kg) during anesthetic induction.

Treatment:

Drug: Methylprednisolone

Placebo

Placebo Comparator group

Description:

Neonates with congenital heart disease requiring surgery utilizing cardiopulmonary bypass (CPB) in the first month of life that receive one dose of placebo (normal saline) during anesthetic induction.

Treatment:

Drug: Placebo