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Effect of Intraoperative Dexamethasone on Major Complications and Mortality Among Infants Undergoing Cardiac Surgery:
Vladimir Lomivorotov1,2, Igor Kornilov1, Vladimir Boboshko1
1E. N. Meshalkin National Medical Research Center, Novosibirsk, Russia.
Insights
Intraoperative dexamethasone did not significantly reduce major complications or mortality in infants undergoing cardiac surgery. Further research may be needed to confirm these findings in pediatric cardiac surgery patients.
Area of Science:
- Pediatric Cardiac Surgery
- Pharmacology
- Critical Care Medicine
Background:
- Corticosteroids are frequently used in pediatric cardiac surgery to mitigate the systemic inflammatory response and decrease complication rates.
- However, the definitive clinical effectiveness of corticosteroids in this patient population remains uncertain.
- This study investigates the role of dexamethasone in improving outcomes for infants undergoing complex cardiac procedures.
Purpose of the Study:
- To evaluate the efficacy of intraoperative dexamethasone compared to a placebo in reducing major complications and mortality.
- The study aimed to provide evidence-based guidance for the use of corticosteroids in pediatric cardiac surgery.
Main Methods:
- A multicenter, double-blind, randomized trial involving 394 infants under 12 months undergoing cardiac surgery with cardiopulmonary bypass.
- Participants received either 1 mg/kg of dexamethasone or an equivalent volume of 0.9% sodium chloride (placebo) intraoperatively.
- The primary endpoint was a composite of death, myocardial infarction, need for ECMO or CPR, acute kidney injury, prolonged mechanical ventilation, or neurological complications within 30 days.
Main Results:
- The primary composite endpoint occurred in 38.1% of the dexamethasone group versus 45.5% in the placebo group, a difference that was not statistically significant (absolute risk reduction, 7.4%; 95% CI, -0.8% to 15.3%; P=.20).
- None of the 17 prespecified secondary endpoints demonstrated a statistically significant difference between the dexamethasone and placebo groups.
- Infection rates were low and comparable between the groups (2.0% vs 1.5%).
Conclusions:
- Intraoperative dexamethasone administration did not significantly decrease major complications or mortality at 30 days in infants undergoing cardiac surgery with cardiopulmonary bypass when compared to placebo.
- The study might have been underpowered to detect a clinically significant difference.
- Further investigation is warranted to clarify the role of dexamethasone in pediatric cardiac surgery.
Importance:
Corticosteroids 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 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.
Interventions:
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.
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.
Trial Registration:
ClinicalTrials.gov Identifier: NCT02615262.
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