Methylprednisolone for infant heart surgery: Subpopulation analyses of a randomized controlled trial

Authors

Sudeep D. Sunthankar, Thomas 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.
Kevin D. Hill, Division of Pediatric Cardiology, Duke University Medical Center, Durham, NC.
Jeffrey P. Jacobs, Division of Cardiac Surgery, University of Florida, Gainesville, FL.
H Scott Baldwin, Thomas 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.
Marshall L. Jacobs, Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore, MD.
Jennifer S. Li, Division of Pediatric Cardiology, Duke University Medical Center, Durham, NC.
Eric M. Graham, Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC.
Brian Blasiole, Division of Pediatric Cardiac Anesthesiology, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA.
S Adil Husain, Division of Cardiac Surgery, Primary Children's Hospital, Salt Lake City, UT.
Mark S. Bleiweis, Division of Cardiac Surgery, University of Florida, Gainesville, FL.
Bret Mettler, Division of Cardiac Surgery, Johns Hopkins School of Medicine, Baltimore, MD.
Alexis Benscoter, Division of Pediatric Cardiology, Cincinnati Children's Hospital, Cincinnati, OH.
Eric Wald, Division of Pediatric Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL.
Tara Karamlou, Division of Cardiac Surgery, Cleveland Clinic, Cleveland, OH.
Andrew H. Van Bergen, Advocate Health - MidwestFollow
Pirooz Eghtesady, Division of Cardiac Surgery, Washington University School of Medicine, St. Louis, MO.
John P. Scott, Division of Pediatric Cardiology, Medical College of Wisconsin, Madison, WI.
Brett R. Anderson, Division of Pediatric Cardiology, Icahn School of Medicine at Mt Sinai, New York, NY.
George Alfieris, Division of Cardiac Surgery, University of Rochester, Rochester, NY.
David F. Vener, Division of Pediatric Cardiac Anesthesiology, Texas Children's Hospital, Baylor College of Medicine, Houston, TX.
Prince J. Kannankeril, Thomas 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.

Recommended Citation

Sunthankar SD, Hill KD, Jacobs JP, et al. Methylprednisolone for Infant Heart Surgery: Subpopulation Analyses of a Randomized Controlled Trial. Crit Care Med. 2025;53(7):e1470-e1480. doi:10.1097/CCM.0000000000006721

Affiliations

Advocate Children's Hospital

Abstract

Objectives: Evaluate benefits and harms of prophylactic intraoperative methylprednisolone in subpopulations undergoing infant heart surgery.

Design: Subpopulation analyses of The Steroids to Reduce Systemic Inflammation after Infant Heart Surgery (STRESS) trial, a double-blind randomized placebo-controlled trial.

Setting: Twenty-four congenital heart centers.

Patients: Infants (< 1 yr old) undergoing heart surgery with cardiopulmonary bypass. Patients stratified by Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery Congenital Heart Surgery (STAT) mortality category, age, gestational age, and presence of chromosomal or syndromic diagnosis (CSD).

Interventions: Methylprednisolone (30 mg/kg) vs. placebo administered into cardiopulmonary bypass pump-priming fluid.

Measurements and main results: Six postoperative outcomes: steroid use, acute kidney injury (AKI), thrombosis, infections, prolonged mechanical ventilation, peak blood glucose levels, and insulin exposure. One thousand two hundred patients received methylprednisolone or placebo. Beneficial effects associated with methylprednisolone included reduced use of postoperative hydrocortisone in neonates (odds ratio [OR], 0.39 [0.25-0.60]), both STAT category groups (1-3: OR, 0.64 [0.46-0.89]; 4-5: OR, 0.57 [0.34-0.97]), term infants (OR, 0.63 [0.47-0.83]), and those without CSD (OR, 0.63 [0.46-0.86]). Methylprednisolone was associated with lower thrombosis occurrence among neonates (OR, 0.37 [0.16-0.87]) and term infants (OR, 0.38 [0.19-0.75]). Adverse associations included increased thrombosis among premature infants (p = 0.005), increased AKI among neonates (OR, 1.55 [1.02-2.37]) and those following STAT category 1-3 operations (OR, 1.34 [1.02-1.75]), and increased peak blood glucose levels and insulin exposure (all subgroups; p < 0.001). No increase in overall infection or reduction in prolonged mechanical ventilation with methylprednisolone.

Conclusions:Both beneficial and adverse associations were observed with prophylactic methylprednisolone. Reduction in postoperative hydrocortisone administration and absence of increased infection rates are arguments favoring prophylactic methylprednisolone use. Methylprednisolone was associated with increased peak blood glucose levels and a neutral to harmful association with odds of AKI. These data suggest certain subpopulations may benefit from prophylactic intraoperative methylprednisolone without significant harm.

Type

Article

PubMed ID

40396812