Publication Date
2-1-2020
Journal
American Heart Journal
DOI
10.1016/j.ahj.2019.11.016
PMID
31855716
PMCID
PMC7008076
PubMedCentral® Posted Date
2-1-2021
PubMedCentral® Full Text Version
Author MSS
Published Open-Access
yes
Keywords
Anti-Inflammatory Agents, Cardiopulmonary Bypass, Double-Blind Method, Heart Defects, Congenital, Humans, Hyperglycemia, Infant, Infant, Newborn, Infections, Length of Stay, Methylprednisolone, Outcome Assessment, Health Care, Placebos, Postoperative Complications, Registries, Research Design, Systemic Inflammatory Response Syndrome, United States, congenital heart disease, perioperative steroids, trial, cardiopulmonary bypass
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.
Included in
Cardiology Commons, Cardiovascular Diseases Commons, Congenital, Hereditary, and Neonatal Diseases and Abnormalities Commons, Medical Sciences Commons, Pediatrics Commons, Surgery Commons