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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
History of Changes
  Purpose

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.


Condition
Selenium Level

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SEOPCAB: Effect of Heart-lung-machine on Selenium Status of Cardiac Surgical Patients Undergoing Coronary Bypass Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • 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.


Enrollment: 46
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
No heart lung machine
Coronary-artery-disease
Heart lung machine
Coronary artery disease

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01409057

Locations
Germany
University Hospital Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Principal Investigator: Steffen Rex, Dr. med. University Hospital, Aachen
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01409057     History of Changes
Other Study ID Numbers: CTC-A 10-086 SEOPCAB
Study First Received: August 2, 2011
Last Updated: December 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Inflammation parameters
Various blood values
Clinical Outcome
Residence in ICU/ Hospital
 SAPS-Score
SOFA-Score
Duration of artificial respiration

ClinicalTrials.gov processed this record on May 19, 2013