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Methylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial.
Kevin D Hill1, Prince J Kannankeril1, Jeffrey P Jacobs1
1From the Duke Pediatric and Congenital Heart Center (K.D.H., J.W.T., J.S.L.) and the Duke Clinical Research Institute (K.D.H., S.M.O., J.L.K., D.S.G., J.S.L.) - both in Durham, NC; Vanderbilt University Medical Center, Nashville (P.J.K., H.S.B., D.P.B.); the University of Florida Congenital Heart Center, Gainesville (J.P.J., M.B.); Johns Hopkins University School of Medicine, Baltimore (M.L.J., B.M.); the Medical University of South Carolina, Charleston (E.M.G.); the UPMC Children's Hospital of Pittsburgh, Pittsburgh (B.B.); the Section of Pediatric Cardiac Anesthesiology, Texas Children's Hospital, Department of Anesthesiology, Baylor College of Medicine, Houston (A.R., D.F.V.), and the Division of Cardiology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas (R.B.); the University of Utah-Primary Children's Hospital, Salt Lake City (A.S.H.); the University of Southern California and the Heart Institute, Children's Hospital of Los Angeles - both in Los Angeles (S.R.K.); the University of Cincinnati, Cincinnati Children's Hospital Medical Center, Cincinnati (A.B.), the Division of Pediatric Cardiac Surgery, Heart Vascular and Thoracic Institute, Cleveland Clinic Children's, Cleveland (T.K.), and the Department of Cardiothoracic Surgery, Nationwide Children's Hospital, and Ohio State University, Columbus (P.I.M.) - all in Ohio; the Ann and Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago (E.W.), and the Advocate Children's Heart Institute, Advocate Children's Hospital, Division of Pediatric Cardiac Critical Care, Oak Lawn (A.H.V.B.) - both in Illinois; the Division of Cardiovascular Surgery, Children's Minnesota, Minneapolis (D.O.); the Section of Pediatric Cardiothoracic Surgery, Washington University School of Medicine, St. Louis (P.E.); the Division of Cardiology, Department of Pediatrics, Heart Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora (J.S.K.); Children's Wisconsin, Medical College of Wisconsin, Milwaukee (J.P.S.); and the Division of Pediatric Cardiology, New York-Presbyterian Hospital-Columbia University Irving Medical Center, New York (B.R.A.), and the University of Rochester Medical Center, Rochester (M.F.S.) - both in New York.
Prophylactic methylprednisolone did not significantly improve outcomes for infants undergoing heart surgery. The drug was associated with increased postoperative hyperglycemia requiring insulin treatment in infants.
Area of Science:
- Pediatric Cardiology
- Cardiothoracic Surgery
- Clinical Pharmacology
Background:
- Perioperative prophylactic glucocorticoids are commonly used but their efficacy in infants undergoing heart surgery with cardiopulmonary bypass remains unclear.
- The study addresses a critical knowledge gap in pediatric cardiac critical care and surgical outcomes.
Purpose of the Study:
- To determine the effectiveness of prophylactic methylprednisolone in improving outcomes for infants undergoing heart surgery with cardiopulmonary bypass.
- To evaluate the safety profile, specifically the incidence of hyperglycemia, associated with methylprednisolone use in this population.
Main Methods:
- A multicenter, prospective, randomized, placebo-controlled trial was conducted involving 1263 infants (<1 year) undergoing heart surgery with cardiopulmonary bypass.
- Infants received either methylprednisolone or placebo, with outcomes assessed using a ranked composite of death, heart transplantation, major complications, and length of stay.
- Registry data from the Society of Thoracic Surgeons Congenital Heart Surgery Database were utilized for outcome evaluation.
Main Results:
- The primary analysis showed no significant difference in the likelihood of a worse outcome between the methylprednisolone and placebo groups (adjusted odds ratio, 0.86; P=0.14).
- Secondary analyses suggested a potential benefit of methylprednisolone (unadjusted odds ratio, 0.82; win ratio, 1.15).
- However, infants receiving methylprednisolone had a significantly higher incidence of postoperative hyperglycemia requiring insulin (19.0% vs. 6.7%, P<0.001).
Conclusions:
- Prophylactic methylprednisolone did not significantly reduce the likelihood of adverse outcomes in infants undergoing heart surgery with cardiopulmonary bypass.
- The use of methylprednisolone was associated with an increased risk of postoperative hyperglycemia requiring insulin treatment.
- These findings suggest that the risks of methylprednisolone may outweigh the benefits in this specific patient population.

