• Vladimir Lomivorotov, Igor Kornilov, Vladimir Boboshko, Vladimir Shmyrev, Ilya Bondarenko, Ilya Soynov, Alexey Voytov, Stanislav Polyanskih, Oleg Strunin, Alexander Bogachev-Prokophiev, Giovanni Landoni, Nigro Neto Caetano C Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil., Gretel Oliveira Nicolau, Leonardo Saurith Izquierdo, Vinícius Nogueira Nascimento, Zhang Wen, Hu Renjie, Zhang Haibo, Vladlen Bazylev, Mikhail Evdokimov, Shahrijar Sulejmanov, Aleksei Chernogrivov, and Dmitry Ponomarev.
• E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.
• JAMA. 2020 Jun 23; 323 (24): 2485-2492.

ImportanceCorticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain.ObjectiveTo 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.ResultsAll 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 RelevanceAmong 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.Trial RegistrationClinicalTrials.gov Identifier: NCT02615262.

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