1. The use of intraoperative dexamethasone in infants undergoing elective cardiac surgery with cardiopulmonary bypass did not significantly reduce major complications or mortality compared to placebo.
2. While most outcomes were comparable between the two groups, mean blood glucose levels were higher in the dexamethasone group 24 hours post-surgery.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Systemic inflammation following cardiopulmonary bypass is a known complication that has been associated with organ dysfunction and prolonged hospitalization. Yet, the perioperative use of immunosuppressive agents, such as corticosteroids, has yielded controversial results. This study evaluated the efficacy of intraoperative dexamethasone and placebo for the reduction of mortality and other complications following pediatric cardiac surgery in patients 12 months old or younger. Findings suggest that intraoperative administration of dexamethasone did not significantly reduce the event of major complications or mortality compared to placebo. With the lack of established guidelines for corticosteroid use in pediatric cardiac surgery, the findings from this study may guide our development of future perioperative procedures. Nonetheless, the double-blind approach and establishment of unambiguous pre-specified outcome measures allowed for the collection and analysis of objective data. This study was limited by its relatively short follow-up of one month post-operation which may not provide adequate insight on long-term outcomes. In addition, while many outcomes were evaluated, this study failed to report data on the relative levels of inflammatory agents, both pro- and anti-inflammatory.
In-Depth [randomized controlled trial]: In this randomized, double-blind clinical trial, 394 infants, ages 12 months or younger, were recruited across 4 centres in Brazil, China, and Russia between December 2015 and October 2018. These pediatric patients were considered for enrollment if they were scheduled for elective cardiac surgery with cardiopulmonary bypass. Major exclusion criteria included the need for emergency surgery, infection up to 30 days prior, and use of steroids, inotropes, and/or mechanical ventilation prior to cardiac surgery. Participants were randomized to receive either 1 mg/kg of dexamethasone or an equivolume of 0.9% sodium chloride (placebo). Treatments were administered to both groups intravenously immediately after anesthesia. All patients had follow-ups through phone calls either 30 days after enrollment or at the end of hospitalization, if the stay had exceeded 30 days. The primary end point was a composite score that includes the following: death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation (≥24 hours), and neurologic events such as stroke, coma, or seizures. Study results indicated that there were no significant differences in composite scores with 38.1% of patients in the dexamethasone group reporting at least one primary outcome event compared to the 45.5% for patients who received placebo (absolute risk reduction, 7.4%, 95% confidence interval [CI], -0.8% to 15.3%; hazard ratio [HR], 0.82, 95% CI, 0.60 to 1.10; P = 0.20). Similarly, when individual components of the composite score were assessed separately, there were no statistical differences between patients who received dexamethasone or placebo. For example, the percentages of patients who required prolonged mechanical ventilation were 36.1% and 42.0% in the dexamethasone and placebo groups, respectively (absolute risk reduction, 5.9%, 95% CI, -2.1% to 13.8%; HR, 0.83, 95% CI, 0.61 to 1.14; P = 0.25).
©2020 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.