High-dose Selenium Supplementation in Patients With Left Ventricular Assist

PHASE3CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

August 31, 2015

Primary Completion Date

July 31, 2017

Study Completion Date

January 31, 2018

Conditions
Ventricular Dysfunction, Left
Interventions
DRUG

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)."

DRUG

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)."

Trial Locations (1)

52074

Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen, Aachen

All Listed Sponsors
collaborator

biosyn Arzneimittel GmbH

INDUSTRY

collaborator

Cardiodevice Stiftung

UNKNOWN

lead

RWTH Aachen University

OTHER

NCT02530788 - High-dose Selenium Supplementation in Patients With Left Ventricular Assist | Biotech Hunter | Biotech Hunter