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Effect of Postop Steroids on Cardiovascular/Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heart Disease Congenital Complex

Intervention: Hydrocortisone (Drug); Normal Saline (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Jeffrey Alten, MD, Principal Investigator, Affiliation: UAB Pediatric Critical Care


This protocol is designed to offer insight into critical illness related corticosteroid insufficiency and steroid supplementation in neonates undergoing cardiac surgery with cardiopulmonary bypass by administering exogenous steroids in the immediate post-operative period.

Clinical Details

Official title: Effect of Postoperative Hydrocortisone on Cardiovascular and Respiratory Function in Neonates Undergoing Cardiopulmonary Bypass

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Average Inotrope Score

Secondary outcome:

Inotrope Score

Alive, ventilator free days

Hospital Length of stay

Changes in baseline inflammatory mediators

Low Cardiac Output Syndrome (LCOS)

Total fluid bolus

Changes in baseline alveolar-arterial oxygen difference

Changes in dynamic lung compliance

Duration of oxygen therapy

CICU length of stay


ACTH Stimulation Test

Post-op Cortisol

Post-op ACTH

Detailed description: Open-heart surgery with cardiopulmonary bypass (CPB) induces an acute systemic inflammatory response (SIRS) via synthesis and release of inflammatory mediators. These inflammatory cascades may result in the development of capillary leak and generalized tissue edema, which are associated with multiorgan dysfunction involving the myocardium, lungs, kidneys, pancreas, and central nervous system. Neonates are especially susceptible to the injurious effects of SIRS. In attempt to blunt post-bypass SIRS, most neonatal heart programs have protocols in which patients receive preoperative and/or intraoperative steroids. Despite this widespread use, studies have not demonstrated consistent benefit in this therapy, and neonates often continue to suffer the deleterious effects of SIRS postoperatively. Only one study was designed to evaluate the impact of prophylactic postoperative steroid administration on outcomes after neonatal CPB. The early postoperative periods is a crucial time during which attenuation of CPB-induced SIRS by exogenous steroids may lead to improved clinical outcomes. Adrenal insufficiency in neonates post-CPB may accentuate the harmful effects of SIRS by diminishing the anti-inflammatory and hemodynamic stabilization benefits of endogenous cortisol. Evidence suggests that neonates may suffer from inadequate cortisol activity relative to the severity of illness post-CPB, in part related to immaturity of their hypothalamic-pituitary-adrenal (HPA) axis. This so-called critical illness-related corticosteroids insufficiency (CIRCI) may contribute to low cardiac output syndrome (LCOS), respiratory dysfunction, and capillary leak in the postoperative period. Much of the support for CIRCI as a contributor to LCOS after CPB originates from small clinical studies that demonstrate benefit of exogenous steroid supplementation on various short term clinical outcomes in patients with shock. Yet it is not clear if benefit from exogenous steroids suggests by dysregulation of the HPA axis or whether these are merely alternative effects of steroids. Investigators have recently begun to describe the cortisol response in neonates post-CPB, but there is no consensus regarding the incidence of clinically important adrenal insufficiency, its identification, or who should receive exogenous steroids.


Minimum age: N/A. Maximum age: 2 Years. Gender(s): Both.


Inclusion Criteria: 1. Neonate (< 28 days old) undergoing correct cardiac surgery, or infants undergoing the following surgery procedures: Norwood, Arterial Switch, Total Anomalous Pulmonary Venous Return Repair, Interrupted Aortic Arch Repair, Truncus Arteriosus Repair 2. Successfully weaned off cardiopulmonary bypass after cardiac surgery Exclusion Criteria: 1. requirement for extracorporeal membrane oxygenation (ECMO) in the operating room 2. Known immune deficiency 3. Having previously received systemic steroids (except for two routine preoperative doses) 4. A current signed Do not resuscitate (DNR) or limitation of care order 5. Current enrollment in another interventional clinical study 6. Refusal of parental consent 7. Previous diagnosis of adrenal insufficiency 8. > 28 days old at time of surgery whose repair dose not require CPB

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35233, United States
Additional Information

Starting date: April 2012
Last updated: January 3, 2014

Page last updated: August 23, 2015

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