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

Publication ,  Journal Article
Hill, KD; Baldwin, HS; Bichel, DP; Butts, RJ; Chamberlain, RC; Ellis, AM; Graham, EM; Hickerson, J; Hornik, CP; Jacobs, JP; Jacobs, ML; Li, JS ...
Published in: Am Heart J
February 2020

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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Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2020

Volume

220

Start / End Page

192 / 202

Location

United States

Related Subject Headings

  • United States
  • Systemic Inflammatory Response Syndrome
  • Research Design
  • Registries
  • Postoperative Complications
  • Placebos
  • Outcome Assessment, Health Care
  • Methylprednisolone
  • Length of Stay
  • Infections
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Hill, K. D., Baldwin, H. S., Bichel, D. P., Butts, R. J., Chamberlain, R. C., Ellis, A. M., … STRESS Network Investigators, . (2020). Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial. Am Heart J, 220, 192–202. https://doi.org/10.1016/j.ahj.2019.11.016
Hill, Kevin D., H Scott Baldwin, David P. Bichel, Ryan J. Butts, Reid C. Chamberlain, Alicia M. Ellis, Eric M. Graham, et al. “Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.Am Heart J 220 (February 2020): 192–202. https://doi.org/10.1016/j.ahj.2019.11.016.
Hill KD, Baldwin HS, Bichel DP, Butts RJ, Chamberlain RC, Ellis AM, et al. Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial. Am Heart J. 2020 Feb;220:192–202.
Hill, Kevin D., et al. “Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.Am Heart J, vol. 220, Feb. 2020, pp. 192–202. Pubmed, doi:10.1016/j.ahj.2019.11.016.
Hill KD, Baldwin HS, Bichel DP, Butts RJ, Chamberlain RC, Ellis AM, Graham EM, Hickerson J, Hornik CP, Jacobs JP, Jacobs ML, Jaquiss RD, Kannankeril PJ, O’Brien SM, Torok R, Turek JW, Li JS, STRESS Network Investigators. Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial. Am Heart J. 2020 Feb;220:192–202.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2020

Volume

220

Start / End Page

192 / 202

Location

United States

Related Subject Headings

  • United States
  • Systemic Inflammatory Response Syndrome
  • Research Design
  • Registries
  • Postoperative Complications
  • Placebos
  • Outcome Assessment, Health Care
  • Methylprednisolone
  • Length of Stay
  • Infections