Dexamethasone does not reduce complications after cardiac surgery in infants vs. placebo
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Dexamethasone did not significantly reduce major complications and mortality at 30 days in infants who underwent cardiac surgery with cardiopulmonary bypass compared with placebo, according to findings from the DECISION trial.
In the randomized, double-blind, placebo-controlled trial published in JAMA, Vladimir Lomivorotov, MD, PhD, head of the department of anesthesiology and intensive care at Novosibirsk Research Institution of Circulation Pathology at Novosibirsk State University in Russia, and colleagues analyzed data from 394 infants (median age, 6 months; 47% boys) younger than 12 months who were scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.
Infants were assigned 1 mg/kg of dexamethasone or an equivolume of 0.9% sodium chloride, which was used as placebo. Assigned drugs were administered through an IV after anesthesia induction.
The primary endpoint for this trial was a composite of nonfatal MI, death, CPR, need for extracorporeal membrane oxygenation, prolonged mechanical ventilation, acute kidney injury and neurologic event (seizures, stroke or coma). Secondary endpoints included 17 components such as use of a pacemaker, duration of ICU stay and individual elements of the primary composite endpoint.
The primary endpoint was observed in 38.1% of infants assigned dexamethasone compared with 45.5% of those assigned placebo (absolute risk reduction, 7.4%; 95% CI, 0.8 to 15.3; HR = 0.82; 95% CI, 0.6-1.1).
There were no statistically significant differences between groups regarding the 17 prespecified secondary endpoints.
Two percent of the dexamethasone group and 1.5% of the control group had confirmed infections.
“This study has several limitations,” Lomivorotov and colleagues wrote. “First, the trial might have overestimated the treatment effect and might be underpowered because the 95% CIs for the between-group difference in the primary endpoint included the minimally clinically important difference of 15%. Second, because proinflammatory and anti-inflammatory cytokines were not measured, it is unclear whether the dose of 1 mg/kg of dexamethasone was effective in reducing systemic inflammatory reaction. Nevertheless, the dose was sufficient to induce laboratory differences between groups (ie, hyperglycemia).”
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