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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01409057
First received: August 2, 2011
Last updated: December 11, 2012
Last verified: December 2012

August 2, 2011
December 11, 2012
June 2010
August 2012   (final data collection date for primary outcome measure)
  • Perioperative serum levels of selenium [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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) [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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.
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Complete list of historical versions of study NCT01409057 on ClinicalTrials.gov Archive Site
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Effect of Heart-lung-machine on Selenium Status of Cardiac Surgical Patients Undergoing Coronary Bypass Surgery
SEOPCAB: Effect of Heart-lung-machine on Selenium Status of Cardiac Surgical Patients Undergoing Coronary Bypass Surgery

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Approximately 100 adult patients (male and female), capable of consenting, undergoing cardiac surgery.

Selenium Level
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  • No heart lung machine
    Coronary-artery-disease
  • Heart lung machine
    Coronary artery disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
December 2012
August 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01409057
CTC-A 10-086 SEOPCAB
No
RWTH Aachen University
RWTH Aachen University
Not Provided
Principal Investigator: Steffen Rex, Dr. med. University Hospital, Aachen
RWTH Aachen University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP