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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01409057

Acronym

SEOPCAB

Enrollment

Registered

2011-08-03

Start date

2010-06-30

Completion date

2012-12-31

Last updated

2012-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Selenium Level

Keywords

Inflammation parameters, Various blood values, Clinical Outcome, Residence in ICU/ Hospital, SAPS-Score, SOFA-Score, Duration of artificial respiration

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Germany

Outcome results