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List of authors.- Kevin D. Hill, M.D., M.S.C.I.,
- Prince J. Kannankeril, M.D., M.S.C.I.,
- Jeffrey P. Jacobs, M.D.,
- H. Scott Baldwin, M.D.,
- Marshall L. Jacobs, M.D.,
- Sean M. O’Brien, Ph.D.,
- David P. Bichel, M.D.,
- Eric M. Graham, M.D.,
- Brian Blasiole, M.D., Ph.D.,
- Ashraf Resheidat, M.D.,
- Adil S. Husain, M.D.,
- S. Ram Kumar, M.D., Ph.D.,
- Jerry L. Kirchner, B.S., C.C.R.P.,
- Dianne S. Gallup, M.S.,
- Joseph W. Turek, M.D., Ph.D.,
- Mark Bleiweis, M.D.,
- Bret Mettler, M.D.,
- Alexis Benscoter, M.D.,
- Eric Wald, M.D.,
- Tara Karamlou, M.D.,
- Andrew H. Van Bergen, M.D.,
- David Overman, M.D.,
- Pirooz Eghtesady, M.D.,
- Ryan Butts, M.D.,
- John S. Kim, M.D.,
- John P. Scott, M.D.,
- Brett R. Anderson, M.D.,
- Michael F. Swartz, Ph.D.,
- Patrick I. McConnell, M.D.,
- David F. Vener, M.D.,
- and Jennifer S. Li, M.D., M.H.S.
- for the STRESS Network Investigators*
Abstract
Background
Although perioperative prophylactic glucocorticoids person been utilized for decades, whether they amended outcomes successful infants aft bosom country with cardiopulmonary bypass is unknown.
Methods
We conducted a multicenter, prospective, randomized, placebo-controlled, registry-based proceedings involving infants (<1 twelvemonth of age) undergoing bosom country with cardiopulmonary bypass astatine 24 sites participating successful the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry information were utilized successful the valuation of outcomes. The infants were randomly assigned to person prophylactic methylprednisolone (30 mg per kilogram of assemblage weight) oregon placebo, which was administered into the cardiopulmonary-bypass pump-priming fluid. The superior extremity constituent was a ranked composite of death, bosom transplantation, oregon immoderate of 13 large complications. Patients without immoderate of these events were assigned a ranked result based connected postoperative magnitude of stay. In the superior analysis, the ranked outcomes were compared betwixt the proceedings groups with the usage of likelihood ratios adjusted for prespecified hazard factors. Secondary analyses included an unadjusted likelihood ratio, a triumph ratio, and information outcomes.
Results
A full of 1263 infants underwent randomization, of whom 1200 received either methylprednisolone (599 infants) oregon placebo (601 infants). The likelihood of a worse result did not disagree importantly betwixt the methylprednisolone radical and the placebo radical (adjusted likelihood ratio, 0.86; 95% assurance interval [CI], 0.71 to 1.05; P=0.14). Secondary analyses (unadjusted for hazard factors) showed an likelihood ratio for a worse result of 0.82 (95% CI, 0.67 to 1.00) and a triumph ratio of 1.15 (95% CI, 1.00 to 1.32) successful the methylprednisolone radical arsenic compared with the placebo group, findings suggestive of a payment with methylprednisolone; however, patients successful the methylprednisolone radical were much apt than those successful the placebo radical to person postoperative insulin for hyperglycemia (19.0% vs. 6.7%, P<0.001).
Conclusions
Among infants undergoing country with cardiopulmonary bypass, prophylactic usage of methylprednisolone did not importantly trim the likelihood of a worse result successful an adjusted investigation and was associated with postoperative improvement of hyperglycemia warranting insulin successful a higher percent of infants than placebo. (Funded by the National Center for Advancing Translational Sciences and others; STRESS ClinicalTrials.gov number, NCT03229538.)
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Sign InFunding and Disclosures
Supported by grants from the National Centers for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) (U01TR-001803-01 and U24TR-001608-03), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the NIH (U18FD-006298-02), the Trial Innovation Network (5U24TR001608-06, funded done NCATS), and the Pediatric Trials Network (HHSN275201800003I and HHSN27500001, funded done NICHD).
Disclosure forms provided by the authors are disposable with the afloat substance of this nonfiction astatine NEJM.org.
This nonfiction was published connected November 6, 2022, astatine NEJM.org.
A data sharing statement provided by the authors is disposable with the afloat substance of this nonfiction astatine NEJM.org.
Author Affiliations
From 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.) — some successful 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 — some successful 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.) — each successful 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.) — some successful 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.) — some successful New York.
Dr. Hill tin beryllium contacted astatine [email protected] oregon astatine the Division of Pediatric Cardiology, Duke University Medical Center, 2301 Erwin Rd., Durham, NC 27506.
The STRESS Network Investigators are listed successful the Supplementary Appendix, disposable astatine NEJM.org.
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