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Methylprednisolone for Infant Heart Surgery: Subpopulation Analyses of a Randomized Controlled Trial
Sudeep D Sunthankar1, Kevin D Hill2, Jeffrey P Jacobs3
1Thomas P. Graham Jr. Division of Pediatric Cardiology and Center for Pediatric Precision Medicine, Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt and Vanderbilt University Medical Center, Nashville, TN.
Prophylactic intraoperative methylprednisolone in infant heart surgery showed benefits like reduced hydrocortisone use but also risks including increased thrombosis in premature infants and higher blood glucose. Certain infant groups may benefit without significant harm.
Area of Science:
- Cardiology
- Pediatric Surgery
- Pharmacology
Background:
- Infant heart surgery carries risks of systemic inflammation and complications.
- Prophylactic corticosteroids are used to mitigate these risks.
- The STRESS trial investigated methylprednisolone's efficacy and safety.
Purpose of the Study:
- To evaluate the benefits and harms of prophylactic intraoperative methylprednisolone in specific subpopulations of infants undergoing heart surgery.
- To identify subgroups that may benefit from or be harmed by this intervention.
Main Methods:
- Subpopulation analyses from the STRESS trial, a double-blind, randomized, placebo-controlled study.
- Infants (<1 year) undergoing heart surgery with cardiopulmonary bypass were stratified by STAT category, age, gestational age, and CSD.
- Methylprednisolone (30 mg/kg) or placebo was administered during cardiopulmonary bypass.
Main Results:
- Methylprednisolone reduced postoperative hydrocortisone use in neonates, STAT categories 1-5, term infants, and those without CSD.
- Lower thrombosis rates were observed in neonates and term infants receiving methylprednisolone.
- Adverse effects included increased thrombosis in premature infants, increased AKI in neonates and STAT 1-3 groups, and elevated peak blood glucose and insulin levels across subgroups.
Conclusions:
- Prophylactic methylprednisolone demonstrated both benefits (reduced hydrocortisone, no increased infection) and harms (increased glucose, potential AKI risk).
- Specific subpopulations may benefit from its use, but careful consideration of risks is necessary.
- Further research may refine patient selection for optimal outcomes.
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