Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial

Kevin D. Hill, H. Scott Baldwin, David P. Bichel, Ryan J. Butts, Reid C. Chamberlain, Alicia M. Ellis, Eric M. Graham, Jesse Hickerson, Christoph P. Hornik, Jeffrey P. Jacobs, Marshall L. Jacobs, Robert DB Jaquiss, Prince J. Kannankeril, Sean M. O'Brien, Rachel Torok, Joseph W. Turek, Jennifer S. Li

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)192-202
Number of pages11
JournalAmerican heart journal
Volume220
DOIs
StatePublished - Feb 2020

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ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Hill, K. D., Baldwin, H. S., Bichel, D. P., Butts, R. J., Chamberlain, R. C., Ellis, A. M., Graham, E. M., Hickerson, J., Hornik, C. P., Jacobs, J. P., Jacobs, M. L., Jaquiss, R. DB., Kannankeril, P. J., O'Brien, S. M., Torok, R., Turek, J. W., & Li, J. S. (2020). Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial. American heart journal, 220, 192-202. https://doi.org/10.1016/j.ahj.2019.11.016