SodiUm SeleniTe Administration IN Cardiac Surgery (SUSTAIN CSX®-trial):
A multicentre randomized controlled trial of high dose sodium-selenite administration in high risk cardiac surgical patients
Background: A significant number of patients require cardiac surgery for the management of their heart disease. In addition to death, major morbidity from organ failure remains all too frequent following open heart surgery, particularly in patients at high-risk for complications and poor clinical outcomes. Such patients require life-sustaining therapies while their organs recover. Especially in older patients, the serious life-threatening complications may negate any benefit from correction of cardiac disease. These complications are in part due to inflammation and oxidative stress caused by the surgery itself. Selenium is a trace element that is important for many of the body's regulatory and metabolic functions, especially during times of stress.
Objectives: Our program of research aims to evaluate the effect of high-dose perioperative selenium administration in patients undergoing high risk cardiac surgery.
Study Population: Male and female adult patients scheduled to undergo elective or urgent cardiac surgery in the near future.
Methods: Patients will receive daily perioperative treatment of either high-dose selenium as sodium-selenite administration or placebo. All patients will receive an IV bolus of 2000µg selenium or the same volume of normal saline (placebo) within 30min after induction of anesthesia, another 2000µg selenium or placebo after termination of surgery, Then 1000µg selenium or placebo over 1-2 hours on every further morning during ICU-stay, until death, discharge from ICU to the ward (treatment may continue in a step down or intermediate care unit), or for a maximum of 10 days. The primary outcome for the definitive trial is persistent organ dysfunction (PODS) + death 30 days post-ICU admission.
Definitive Trial:The Clinical Evaluation Research Unit has received funding from a non-profit research foundation. The pilot was funded by the Canadian Institute of Health Research (CIHR).
Recruitment:Site recruitment for the definitive trial is currently underway.
This trial is registered at ClinicalTrials.gov (NCT02002247). The trial aims to enroll 1400 patients altogether, including pilot patients.