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Methylprednisolone for Heart Surgery in Infants

Prophylactic methylprednisolone failed to significantly reduce the likelihood of a worse outcome among infants undergoing surgery with cardiopulmonary bypass, researchers report. The steroid was also associated with development of hyperglycemia requiring insulin therapy.

In a multicenter, prospective, randomized, placebo-controlled, registry-based trial of 1,263 infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass, infants were randomized to prophylactic methylprednisolone 30 mg/kg or placebo administered into the cardiopulmonary-bypass pump-priming fluid. Based on a primary endpoint of a ranked composite of death, heart transplantation, or any of 13 major complications, study results showed the following: “The likelihood of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86; 95% confidence interval [CI], 0.71 to 1.05; P = 0.14). Secondary analyses (unadjusted for risk factors) showed an odds ratio for a worse outcome of 0.82 (95% CI, 0.67 to 1.00) and a win ratio of 1.15 (95% CI, 1.00 to 1.32) in the methylprednisolone group as compared with the placebo group, findings suggestive of a benefit with methylprednisolone; however, patients in the methylprednisolone group were more likely than those in the placebo group to receive postoperative insulin for hyperglycemia (19.0% vs. 6.7%, P <0.001).”

Source: New England Journal of Medicine