Effect of Heart-lung-machine on Selenium Status of Cardiac Surgical Patients Undergoing Coronary Bypass Surgery

Study Overview
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Brief Summary
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Since selenium has demonstrated significant characteristics for a series of biochemical processes, for antioxidant activity and immune stimulation, this observational study should represent the effect of heart-lung-machine on selenium status of cardiac surgical patients undergoing coronary bypass surgery. It will be examined in (approximately 100) adult patients, under which 50 patients are operated conventionally (meaning with the use of heart-lung-machine). Another 50 patients are operated on beating heart without the use of heart-lung-machine (OPCAB = off pump coronary artery bypass). The allocation of individual patients in these two groups is done according to clinical criteria and is undertaken by the operating surgeon.

Detailed Description
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To produce two comparable groups of patients, the characteristics are recorded using EURO-Score; additionally the groups are matched (Matched-Pairs-Analysis). All patients are operated by the same surgeon (senior physician Dr. A.K. Menon) under general anaesthesia through median sternotomy with elective or urgent indications. After induction of anaesthesia, within the first hour after admission to the Intensive Care Unit (ICU) and every further morning in the ICU or Intermediate Care Station (IMC), 10ml blood are removed by a central venous catheter, allowing to measure blood selenium levels in whole blood by electrothermal atomic absorption spectrometry. All blood draws will be held on vascular access, which is lying independently of the study participation for surgery or for intensive care treatment. The blood samples will be stored until completion of the study and its evaluation (up to 24 months) and are discarded afterwards. All data collected are recorded on a documentation sheet.

Official Title
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SEOPCAB: Effect of Heart-lung-machine on Selenium Status of Cardiac Surgical Patients Undergoing Coronary Bypass Surgery

Conditions
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Selenium Level

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary-3-vessel-disease Written informed consent Age of 18 years or older Study inclusion at the latest on the last evening before surgery Exclusion Criteria: Other serious cardiac diagnosis (i.e. aneurysm, valvular-diseases) ischemic cardiomyopathy Patients not capable of consenting Pregnant or lactating women, women of child-bearing potential in whom pregnancy can not be excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No heart lung machine<br>Coronary-artery-disease | |
| Heart lung machine<br>Coronary artery disease | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative serum levels of selenium | Perioperative serum levels of selenium in patients undergoing either conventional cardiac surgery with the use of cardiopulmonary-bypass (CPB) or without use of CPB on beating heart. | 48 hours | 
| Perioperative serum levels of macrophage migration inhibitory factor (MIF) | Perioperative serum levels of macrophage migration inhibitory factor (MIF)in patients undergoing either conventional cardiac surgery with the use of cardiopulmonary-bypass (CPB) or without use of CPB on beating heart. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation parameters, Various blood values, Clinical Outcome, Residence in ICU/ Hospital, SAPS-Score, SOFA-Score, Duration of artificial respiration