Trial Design and Participants
congenital anomalies, arrest, cardiocirculatory arrest, neuropsychiatric disorders, hypersensitivity
HYPERSENSITIVITY, ARREST
We conducted an international, double-blind, randomized placebo-controlled trial, the Sodium Selenite Administration in Cardiac Surgery Trial (SUSTAIN CSX) trial, at 23 sites in Canada and Germany.Patients 18 years or older were eligible if they were scheduled to undergo elective or urgent cardiac surgery with the use of CPB and cardioplegic arrest and were at higher risk of perioperative morbidity and mortality as defined by the European System for Cardiac Operative Risk Evaluation (EuroSCORE) II predicted operative mortality of 5% or more or if combined surgical procedures were planned.Key exclusion criteria were hypersensitivity to sodium selenite or to any of the diluent vehicle, total bilirubin more than 2.0 mg/dL (to convert to micromoles per liter, multiply by 17.104), disabling neuropsychiatric disorders, pregnancy, lactation, current antioxidant use, cardiac transplant, planned ventricular assist device implantation, correction of complex congenital anomalies, or planned use of hypothermic cardiocirculatory arrest. The complete inclusion and exclusion criteria are noted in the trial protocol in 