Preoperative 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: methylprednisolone (two doses IVMP); Drug: methylprednisolone (IVMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT00934843

HR 17030

Details and patient eligibility

About

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

Full 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.

Enrollment: 77 patients

Sex: All

Ages: Under 30 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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77 participants in 2 patient groups

Single dose steroid

Experimental group

Description:

Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose intravenous methylprednisolone (IVMP) prior to heart surgery.

Treatment:

Drug: methylprednisolone (IVMP)

Two Dose steroid

Experimental group

Description:

Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO doses intravenous methylprednisolone (IVMP) prior to heart surgery.Compare the effects and preoperative and intraoperative IVMP to intraoperative IVMP alone on the inflammatory response to CPB cardiopulmonary bypass. The hypothesis is that neonates treated with preoperative IVMP as well as the standard intraoperative IVMP will have decreased production of pro-inflammatory cytokines.

Treatment:

Drug: methylprednisolone (two doses IVMP)