Glucocorticoid prophylaxis of little benefit to infants undergoing cardiopulmonary bypass

Prophylactic use of methylprednisolone does not appear to improve outcomes in infants undergoing cardiopulmonary bypass, even posing an increased risk of hyperglycaemia that requires insulin treatment, according to a study.

The prospective registry-based trial included infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass across 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. A total of 1,263 infants were randomized to receive prophylactic methylprednisolone (30 mg per kilogram of body weight; n=599) or placebo (n=601). Treatment was administered into the cardiopulmonary-bypass pump-priming fluid.

Researchers used registry data to assess outcomes. They evaluated a ranked composite of death, heart transplantation, or any of the 13 major complications as the primary endpoint. Infants who did not develop any of these events were assigned a ranked outcome based on postoperative length of stay.

Multivariable regression analysis showed that infants in the methylprednisolone group had a similar likelihood of a worse outcome as compared with those in the placebo group (adjusted odds ratio [OR], 0.86, 95 percent confidence interval [CI], 0.71–1.05; p=0.14).

In secondary analyses not controlled for risk factors, methylprednisolone was associated with lower odds of a worse outcome (OR, 0.82, 95 percent CI, 0.67–1.00) compared with placebo, with a win ratio of 1.15 (95 percent CI, 1.00–1.32) indicative of a benefit with the active treatment.

However, infants who received methylprednisolone were more likely than those who received placebo to receive postoperative insulin for hyperglycaemia (19.0 percent vs 6.7 percent; p<0.001).