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

Completed

• Conditions: Selenium Level

• Registration Number: NCT01409057
• Lead Sponsor: RWTH Aachen University

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2012-08
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-11
• Last Update Posted: 2012-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative serum levels of selenium	48 hours	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.
Perioperative serum levels of macrophage migration inhibitory factor (MIF)	48 hours	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.

Trial Locations

Locations (1)

University Hospital Aachen; 🇩🇪 Aachen, Germany