Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial - 05/02/20

Doi : 10.1016/j.ahj.2019.11.016

Kevin D. Hill, MDMSCI ^a,^b, H. Scott Baldwin, MD ^c, David P. Bichel, MD ^c, Ryan J. Butts, MD ^d, Reid C. Chamberlain, MD ^a, Alicia M. Ellis, PhD ^b, Eric M. Graham, MD ^e, Jesse Hickerson, MS ^b, Christoph P. Hornik, MD MS ^a,^b, Jeffrey P. Jacobs, MD ^f, Marshall L. Jacobs, MD ^f, Robert DB Jaquiss, MD ^d, Prince J. Kannankeril, MD MSCI ^c, Sean M. O'Brien, PhD ^b, Rachel Torok, MD ^a, Joseph W. Turek, MD PhD ^a, Jennifer S. Li, MD MHS ^a,^b
For the STRESS Network Investigators
Andrew H. Van Bergen, MD ¹, Eric Wald, MD ², Ashraf Resheidat, MD ³, David F. Vener, MD ³, James Jaggers, MD ⁴, S. Ram Kumar, MD, PhD ⁵, James St. Louis, MD ⁶, Jim Hammel, MD ⁷, David Overman, MD ⁸, Brian Blasiole, MD ⁹, Jake P. Scott, MD ¹⁰, Alexis L. Benscoter, DO ¹¹, Tara Karamlou, MD ¹², William J. Ravekes, MD ¹³, George Ofori-Amanfo, MD ¹⁴, Jason R. Buckley, MD ¹⁵, Sinai C. Zyblewski, MD ¹⁵, Patrick McConnell, MD ¹⁶, Brett R. Anderson, MD ¹⁷, Darlene Santana-Acosta, MD ¹⁸, Pirooz Eghtesady, MD ¹⁹, Mark Bleiweis, MD ²⁰, Michael Swartz ²¹, Ryan J. Butts, MD ²², S. Adil Husain, MD ²³, Linda Lambert, APRN ²³, Venugopal Amula, MD ²³, Rusty Eckhauser, MD ²³, Eric Griffiths, MD ²³, Richard Williams, MD ²³, Madolin Witte, MD ²³, LuAnn Minich, MD ²³
¹ Advocate Children's Hospital
² Ann and Robert H. Lurie Children's Hospital of Chicago
³ Baylor College of Medicine, Texas Children's Hospital
⁴ Children's Hospital of Colorado
⁵ Children's Hospital of Los Angeles
⁶ Children's Mercy, Kansas City
⁷ Children's Hospital & Medical Center, Omaha
⁸ Children's Minnesota
⁹ Children's Hospital of Pittsburgh
¹⁰ Children's Hospital of Wisconsin
¹¹ Cincinnati Children's Hospital Medical Center
¹² Cleveland Clinic
¹³ Johns Hopkins Children's Center, Baltimore, Maryland
¹⁴ Kravis Children's Hospital at Mount Sinai
¹⁵ Medical University of South Carolina
¹⁶ Nationwide Children's Hospital
¹⁷ NewYork-Presbyterian/Morgan Stanley Children's Hospital
¹⁸ Nicklaus Children's Hospital
¹⁹ St. Louis Children's Hospital
²⁰ University of Florida Health Shands Hospital
²¹ University of Rochester Medical Center
²² University of Texas Southwestern Medical Center, Dallas
²³ University of Utah Health/Primary Children's Medical Center

^a Duke University Pediatric and Congenital Heart Center, Durham, NC
^b Duke Clinical Research Institute, Durham, NC
^c Vanderbilt University Medical Center, Nashville, TN
^d University of Texas Southwestern, Dallas, TX
^e Medical University of South Carolina, Charleston, SC
^f Johns Hopkins University School of Medicine, Baltimore, MD

Abstract

For decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the postoperative systemic inflammatory response to CPB. Some question this practice because steroid efficacy has not been conclusively demonstrated and because some studies indicate that steroids could have harmful effects. STRESS is a randomized, placebo-controlled, double-blind, multicenter trial designed to evaluate safety and efficacy of perioperative steroids in infants (age < 1 year) undergoing heart surgery with CPB. Participants (planned enrollment = 1,200) are randomized 1:1 to methylprednisolone (30 mg/kg) administered into the CPB pump prime versus placebo. The trial is nested within the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. The primary outcome is a global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity. Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications. STRESS will be one of the largest trials ever conducted in children with heart disease and will answer a decades-old question related to safety and efficacy of perioperative steroids in infants undergoing heart surgery with CPB. The pragmatic “trial within a registry” design may provide a mechanism for conducting low-cost, high-efficiency trials in a heretofore-understudied patient population.

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Plan

	Trial Registration Number: NCT03229538
	Anne Marie Valente, MD, served as guest editor for this article.

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Vol 220

P. 192-202 - février 2020 Retour au numéro

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Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial - 05/02/20

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