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

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.

Study Overview

• Status: Completed
• Conditions: Selenium Level

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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52074
    • University Hospital Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
No heart lung machine; Coronary-artery-disease
Heart lung machine; Coronary artery disease

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Steffen Rex, Dr. med., University Hospital, Aachen

Publications and helpful links

General Publications

• Stevanovic A, Coburn M, Menon A, Rossaint R, Heyland D, Schalte G, Werker T, Wonisch W, Kiehntopf M, Goetzenich A, Rex S, Stoppe C. The importance of intraoperative selenium blood levels on organ dysfunction in patients undergoing off-pump cardiac surgery: a randomised controlled trial. PLoS One. 2014 Aug 13;9(8):e104222. doi: 10.1371/journal.pone.0104222. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): December 12, 2012
• Last Update Submitted That Met QC Criteria: December 11, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Clinical Outcome; Various blood values; Duration of artificial respiration; Residence in ICU/ Hospital; SOFA-Score; SAPS-Score; Inflammation parameters
• Other Study ID Numbers: CTC-A 10-086 SEOPCAB