Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery

Abstract

IMPORTANCECorticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain.OBJECTIVE To determine whether intraoperative administration of dexamethasone is more effective than placebo for reducing major complications and mortality during pediatric cardiac surgery. DESIGN, SETTING, AND PARTICIPANTSThe Intraoperative Dexamethasone in Pediatric Cardiac Surgery was an investigator-initiated, double-blind, multicenter randomized trial that involved 4 centers in China, Brazil, and Russia. A total of 394 infants younger than 12 months, undergoing cardiac surgery with cardiopulmonary bypass were enrolled from December 2015 to October 2018, with follow-up completed in November 2018. INTERVENTIONSThe dexamethasone group (n = 194) received 1 mg/kg of dexamethasone; the control group (n = 200) received an equivolume of 0.9% sodium chloride intravenously after anesthesia induction. MAIN OUTCOMES AND MEASURESThe primary end point was a composite of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, need for cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days after surgery. There were 17 secondary end points, including the individual components of the primary end point, and duration of mechanical ventilation, inotropic index, intensive care unit stay, readmission to intensive care unit, and length of hospitalization.RESULTS All of the 394 patients randomized (median age, 6 months; 47.2% boys) completed the trial. The primary end point occurred in 74 patients (38.1%) in the dexamethasone group vs 91 patients (45.5%) in the control group (absolute risk reduction, 7.4%; 95% CI, −0.8% to 15.3%; hazard ratio, 0.82; 95% CI, 0.60 to 1.10; P = .20). Of the 17 prespecified secondary end points, none showed a statistically significant difference between groups. Infections occurred in 4 patients (2.0%) in the dexamethasone group vs 3 patients (1.5%) in the control group.CONCLUSIONS AND RELEVANCE Among infants younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative administration of dexamethasone, compared with placebo, did not significantly reduce major complications and mortality at 30 days. However, the study may have been underpowered to detect a clinically important difference.

Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial

“…We did not find an association between a history of diabetes and the effect of dexamethasone on the primary outcome. In accordance with our data, it has been shown recently that high doses of dexamethasone administered perioperatively to children after cardiac surgery was not associated with major harm 40…”

“…In accordance with our data, it has been shown recently that high doses of dexamethasone administered perioperatively to children after cardiac surgery was not associated with major harm. 40 …”

“…In accordance with our data, it has been shown recently that high doses of dexamethasone administered perioperatively to children after cardiac surgery was not associated with major harm. 40 strengths and limitations of this study The strengths of this double blind, randomised controlled trial include its large size and the number of participating sites. To reduce variability in the perioperative care of patients, the clinicians were asked to follow local recommendations for antimicrobial prophylaxis, protective ventilation (low tidal volume ventilation), prevention of hypotension, and duration of sedation.…”

Lung Injury After Neonatal Congenital Cardiac Surgery Is Mild and Modifiable by Corticosteroids

“…24 Systemic steroid use has failed to reduce the length of mechanical ventilation after cardiac surgery in pediatric studies, including the present study. 7,8,25,26 Even though in an RCT on adult patients, high-dose dexamethasone helped shorten mechanical ventilation after cardiac surgery, the pediatric study cohorts may have been too small to answer this question. 27 Furthermore, in the present study, because postoperative lung edema was only mild and lung injury scarce, the SDC regimen may have lacked significant effect on major clinical outcomes.…”

Efficacy and safety of corticosteroids prophylaxis in cardiac surgery

“…A large number of randomized controlled trials showed that the prophylactic use of corticosteroids in patients with heart operation under CPB did not bring any benefits, but increased the risk of myocardial infarction, prolonged the time of mechanical ventilation. [ 10 , 13 , 14 , 18 ] Adult cardiac surgery guidelines and clinical routine cardiac surgery in adults and children are not used in preventive corticosteroids. However, the clinical effects of corticosteroids are dose-dependent.…”