Selenium is a trace element that is important for many of the body’s regulatory and metabolic functions. It is fundamental to maintain the functioning of the immune system, especially in patients experiencing oxidative stress. When it comes to cardiac surgery with the use of a cardiopulmonary bypass a significant decrease of the selenium can be observed. Together with a systematic inflammatory response syndrome (SIRS) this is associated with worse clinical outcome. Therefore, our research group is focussing on preventing the decrease during surgery and, consequently, improve the clinical outcome.

Our research group is currently working on two clinical studies in the field of preventive administration of selenium.

SustainCSX

SodiUm SeleniTe Administration IN Cardiac Surgery (SUSTAIN CSX®-trial). A multicentre, randomised controlled trial of high dose sodium-selenite administration in high risk cardiac surgical patients 

SustainCSX is an international multicentre study and is currently recruiting. There are 12 German sites and 12 Canadian sites working on this study. Patients scheduled for elective cardiac surgery with combined procedures or with an EuroScore ≥ 5 will be included. Patients receive in total 4000µg of the investigational product intravenously at the day of surgery and 1000µg postoperatively.

EudraCT-No.: 2013-003088-76

SOS-LVAD

“High Dose Supplementation of Selenium in Left Ventricular Assist Device (LVAD) Implant Surgery – A Double Blind Randomised Controlled Trial”

SOS-LVAD, a monocentre study, is almost the same setting as it is in SustainCSX. However, the focus is on LVAD-patients and IP administration started already at the day before surgery orally and at the day of surgery IP was administered intravenously.

Recruitment is completed and we plan to have first results soon.

EudraCT-No.: 2013-001357-26

 

SOSA

“Selenomethionine vs. Sodium selenite Comparison of Pharmacokinetics of Organic and Inorganic Selenium Preparations in Human Blood Uptake, Storage and Monitoring of Selenium in Cardiac Patients as a Function of Its Pharmaceutical Preparation”

EudraCT-No.: 2016-003600-31