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| Name | Class |
|---|---|
| biosyn Arzneimittel GmbH | INDUSTRY |
| Cardiodevice Stiftung | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selenium Supplement (sodium selenite) | Active Comparator | Active arm receiving Selenium in form of sodium selenite |
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| Placebo | Placebo Comparator | Placebo arm receiving Sodium Chloride solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Selenium Supplement (sodium selenite) | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
| postoperative day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | via telephone enquiry | 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 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Goetzenich, MD, PhD | Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen | Principal Investigator |
| Christian Stoppe, MD | Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Thoracic and Cardiovascular Surgery, University Hospital RWTH Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany |
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| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D018038 | Sodium Selenite |
| ID | Term |
|---|---|
| D020887 | Selenious Acid |
| D018036 | Selenium Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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| Placebo | Drug | 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). |
|
| postoperative day 7 |
| Incidence of nosocomial infections acquired at ICU | participants will be followed for the duration of hospital stay, an expected average of 5-10 days |
| Acute renal failure | (quantified with RIFLE score) | 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 | 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 | 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) | 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. | postoperative day 28 |