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What is the effect of dexamethasone on complications and mortality in infants undergoing cardiac surgery?
In this randomized clinical trial that involved 394 infants, intraoperative administration of dexamethasone 1 mg/kg, compared with placebo, did not significantly reduce the primary composite end point of death, nonfatal myocardial infarction, need for extracorporeal membrane oxygenation, cardiopulmonary resuscitation, acute kidney injury, prolonged mechanical ventilation, or neurological complications (38.1% vs 45.5%, respectively; hazard ratio, 0.82).
Among patients younger than 12 months undergoing cardiac surgery with cardiopulmonary bypass, intraoperative dexamethasone did not significantly reduce major complications and mortality compared with placebo.
Corticosteroids are widely used in pediatric cardiac surgery to blunt systemic inflammatory response and to reduce complications; nevertheless, their clinical efficacy is uncertain.
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 Participants
The 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.
The 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 Measures
The 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.
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.
ClinicalTrials.gov Identifier: NCT02615262
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Corresponding Author: Dmitry Ponomarev, MD, PhD, MSc, E. N. Meshalkin National Medical Research Center, 15 Rechkunovskaya St, Novosibirsk 630055, Russian Federation (email@example.com).
Accepted for Publication: April 30, 2020.
Author Contributions: Dr Ponomarev had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Lomivorotov, Kornilov, Boboshko, Shmyrev, Strunin, Bogachev-Prokophiev, Landoni, Renjie, Ponomarev.
Acquisition, analysis, or interpretation of data: Lomivorotov, Kornilov, Bondarenko, Soynov, Voytov, Polyanskih, Strunin, Landoni, Nigro Neto, Oliveira Nicolau, Saurith Izquierdo, Nogueira Nascimento, W. Zhang, H. Zhang, Bazylev, Evdokimov, Sulejmanov, Chernogrivov, Ponomarev.
Drafting of the manuscript: Lomivorotov, Kornilov, Boboshko, Bondarenko, Soynov, Voytov, Polyanskih, Strunin, Landoni, Saurith Izquierdo, Nogueira Nascimento, W. Zhang, Renjie, H. Zhang, Sulejmanov, Ponomarev.
Critical revision of the manuscript for important intellectual content: Lomivorotov, Kornilov, Shmyrev, Strunin, Bogachev-Prokophiev, Landoni, Nigro Neto, Oliveira Nicolau, Bazylev, Evdokimov, Chernogrivov, Ponomarev.
Statistical analysis: Lomivorotov, Soynov, Polyanskih, Strunin, Landoni, Nogueira Nascimento, Bazylev, Chernogrivov, Ponomarev.
Administrative, technical, or material support: Lomivorotov, Boboshko, Shmyrev, Soynov, Voytov, Strunin, Bogachev-Prokophiev, Oliveira Nicolau, Saurith Izquierdo, Renjie, H. Zhang, Evdokimov, Sulejmanov.
Supervision: Lomivorotov, Bogachev-Prokophiev, Landoni, H. Zhang, Bazylev, Chernogrivov, Ponomarev.
Conflict of Interest Disclosures: None reported.
Funding/Support: This research was supported by local institutional funding only.
Role of the Funder/Sponsor: E. N. Meshalkin National Medical Research Center established an independent data and safety monitoring board to monitor safety and had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 3.
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