1. Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial
- Author
-
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, Andrew H. Van Bergen, Eric Wald, Ashraf Resheidat, David F. Vener, James Jaggers, S. Ram Kumar, James St. Louis, Jim Hammel, David Overman, Brian Blasiole, Jake P. Scott, Alexis L. Benscoter, Tara Karamlou, William J. Ravekes, George Ofori-Amanfo, Jason R. Buckley, Sinai C. Zyblewski, Patrick McConnell, Brett R. Anderson, Darlene Santana-Acosta, Pirooz Eghtesady, Mark Bleiweis, Michael Swartz, S. Adil Husain, Linda Lambert, Venugopal Amula, Rusty Eckhauser, Eric Griffiths, Richard Williams, Madolin Witte, and LuAnn Minich
- Subjects
Research design ,Heart Defects, Congenital ,medicine.medical_specialty ,Inflammatory response ,Anti-Inflammatory Agents ,030204 cardiovascular system & hematology ,Systemic inflammation ,Infections ,Methylprednisolone ,Article ,law.invention ,Placebos ,03 medical and health sciences ,0302 clinical medicine ,Postoperative Complications ,Double-Blind Method ,law ,Multicenter trial ,Outcome Assessment, Health Care ,medicine ,Cardiopulmonary bypass ,Humans ,030212 general & internal medicine ,Registries ,Cardiopulmonary Bypass ,business.industry ,Infant, Newborn ,Infant ,Perioperative ,Length of Stay ,medicine.disease ,Systemic Inflammatory Response Syndrome ,United States ,Surgery ,Systemic inflammatory response syndrome ,Research Design ,Hyperglycemia ,medicine.symptom ,Cardiology and Cardiovascular Medicine ,business ,medicine.drug - Abstract
For 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 (30mg/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. Secondary outcomes include several measures of major post-operative morbidity, post-operative hospital length of stay and steroid-related safety outcomes including prevalence of hyperglycemia and post-operative 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. Trial Registration Number
- Published
- 2019