21
Participants
Start Date
August 31, 2015
Primary Completion Date
July 31, 2017
Study Completion Date
January 31, 2018
Selenium Supplement (sodium selenite)
"On the evening before operation the patient receives the first dosage of Selenium (300µg orally) orally as a pill.~After induction of anaesthesia and before being put on the heart-lung-machine the patient receives 3000µg Selenium as sodium selenite (selenase® T) intravenous (as bolus infusion in the space of 30 minutes). In addition the patient gets 1000µg Selenium as sodium selenite (selenase® T) intravenous as bolus infusion in the space of 30 minutes after admission to ICU. On every POD the patient receives 1000µg Selenium as sodium selenite (selenase® T) intravenous as bolus infusion in the space of 30 minutes (until transfer to standard care unit or maximum substitution until 13th POD)."
Placebo
"On the evening before operation the patient receives the first dosage of placebo orally as a pill.~After induction of anaesthesia and before being put on the heart-lung-machine the patient receives placebo intravenous (as bolus infusion in the space of 30 minutes). In addition the patient gets placebo intravenous as bolus infusion in the space of 30 minutes after admission to ICU. On every POD the patient receives placebo intravenous as bolus infusion in the space of 30 minutes (until transfer to standard care unit or maximum substitution until 13th POD)."
Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen
biosyn Arzneimittel GmbH
INDUSTRY
Cardiodevice Stiftung
UNKNOWN
RWTH Aachen University
OTHER