Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass: Randomized Controlled Trial
| Autor: | Eric M, Graham, Reneé H, Martin, Jason R, Buckley, Sinai C, Zyblewski, Minoo N, Kavarana, Scott M, Bradley, Bahaaldin, Alsoufi, William T, Mahle, Marc, Hassid, Andrew M, Atz |
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| Rok vydání: | 2019 |
| Předmět: |
Heart Defects
Congenital Male Cardiopulmonary Bypass Dose-Response Relationship Drug Incidence Infant Newborn Prognosis Methylprednisolone United States Intraoperative Period Postoperative Complications Double-Blind Method Injections Intravenous Humans Female Cardiac Surgical Procedures Glucocorticoids |
| Zdroj: | Journal of the American College of Cardiology. 74(5) |
| ISSN: | 1558-3597 |
| Popis: | The efficacy of intraoperative corticosteroids to improve outcomes following congenital cardiac operations remains controversial.The purpose of this study was to determine whether intraoperative methylprednisolone improves post-operative recovery in neonates undergoing cardiac surgery.Neonates undergoing cardiac surgery with cardiopulmonary bypass at 2 centers were enrolled in a double-blind randomized controlled trial of methylprednisolone (30 mg/kg) or placebo after the induction of anesthesia. The primary outcome was a previously validated morbidity-mortality composite that included any of the following events following surgery before discharge: death, mechanical circulatory support, cardiac arrest, hepatic injury, renal injury, or rising lactate level (5 mmol/l).Of the 190 subjects enrolled, 176 (n = 81 methylprednisolone, n = 95 placebo) were included in this analysis. A total of 27 (33%) subjects in the methylprednisolone group and 40 (42%) in the placebo group reached the primary study endpoint (odds ratio [OR]: 0.63; 95% confidence interval [CI]: 0.31 to 1.3; p = 0.21). Methylprednisolone was associated with reductions in vasoactive inotropic requirements and in the incidence of the composite endpoint in subjects undergoing palliative operations (OR: 0.38; 95% CI: 0.15 to 0.99; p = 0.048). There was a significant interaction between treatment effect and center. In this analysis, methylprednisolone was protective at 1 center, with an OR: 0.35 (95% CI: 0.15 to 0.84; p = 0.02), and not so at the other center, with OR: 5.13 (95% CI: 0.85 to 30.90; p = 0.07).Intraoperative methylprednisolone failed to show an overall significant benefit on the incidence of the composite primary study endpoint. There was, however, a benefit in patients undergoing palliative procedures and a significant interaction between treatment effect and center, suggesting that there may be center or patient characteristics that make prophylactic methylprednisolone beneficial. |
| Databáze: | OpenAIRE |
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