Rationale and design of the steroids to reduce systemic inflammation after infant heart surgery (stress) trial

Publication date: Available online 9 December 2019Source: American Heart JournalAuthor(s): 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, For the STRESS Network InvestigatorsFor decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the post-operative 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, multi-center trial designed to evaluate safety and efficacy of perioperative steroids in infants (age< 1 year) undergoing heart surgery with CPB. Participants (planned enrollment = 1200) 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 (STS-CHSD). 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....
Source: American Heart Journal - Category: Cardiology Source Type: research