This planned pilot study is a monocentric, prospective, double-blind randomized and placebo controlled clinical study. The SOS-LVAD Trial can be assigned to the clinical Phase III. The aim of the present trial is to provide the scientific rationale for a large multicenter clinical trial, investigating the effects of perioperative high dose selenium supplementation in high-risk cardiac surgical patients undergoing complicated open heart surgery with prolonged time on cardiopulmonary bypass (CPB) and LVAD Implant. The investigators hypothesize that the therapeutic strategy tested in this randomized trial may contribute to a faster independency from life-sustaining technologies in the ICU and a decrease of postoperative morbidity and mortality. Before proceeding to the large-scale, definitive trial, the investigators propose to conduct a pilot study of the definitive randomized trial, to determine the feasibility of the study protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
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).
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, North Rhine-Westphalia, Germany
Composite Outcome: independence from specific ICU procedures
As primary outcome, the investigators have chosen a composite outcome. This allows to assess the postoperative process of the included patients irrespective of extrinsic sources of irritation (e.g. daily routine, clinic based processes). The independency from specific ICU procedures is taken as a primary target (time is taken from postoperative admission to ICU after implantation of LVAD until the end of the characteristic ICU procedures): * mechanical ventilation * vasopressor therapy * mechanical circulatory support * renal replacement therapy
Time frame: postoperative day 28
Mortality
via telephone enquiry
Time frame: postoperative day 28
Persistent organ dysfunction
Persistent organ dysfunction quantified upon day 7 (or upon day of discharge from hospital) with "Sequential Organ Failure Assessment Score" (SOFA), "Multiple Organ Dysfunction Score" (MODS) and "Simplified Acute Physiology Score" (SAPS), daily quantification while ICU stay
Time frame: postoperative day 7
Incidence of nosocomial infections acquired at ICU
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Acute renal failure
(quantified with RIFLE score)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Mechanical Ventilation
Time of mechanical ventilation (measured in hours after successful intubation) and necessity of re-intubation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
postoperative delirium
Evaluation of delirium by confusion assessment method: CAM-ICU score
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-10 days
Selenium concentration in whole blood, activity of glutathion-peroxidase, concentration of Selenoprotein-P (Sel-P)
Time frame: preoperative, by the end of surgery, on day 1, 3, 5, 7, 13, and if the patient is still in hospital, on day 28.
Quality of Life
The patients individual "Quality of Life" (pre- and postoperative) quantified with "MACNEW - Health related quality of life in heart disease - Scale" quantified postoperative upon discharge from hospital and on the 28th POD via telephone inquiry. If the patient cannot be contacted via telephone on the 28th POD, we will try to reach the patient on the following 7 days.
Time frame: postoperative day 28
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