Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery

Completed

• Conditions: Heart Surgery
• Interventions: Procedure: Blood sampling

• Registration Number: NCT01267721
• Lead Sponsor: RWTH Aachen University

Brief Summary

It has been repeatedly demonstrated that cardiac surgery with the use of extracorporeal circulation elicits a systemic inflammatory response and provokes ischemia-reperfusion related oxidative stress which could further lead to the development of organ failure in critically ill patients. Perioperative levels of macrophage migration inhibitory factor (MIF) and other inflammatory mediators could be involved in adverse outcomes in cardiac surgery.

Detailed Description

The trace element selenium (Se) serves as an essential co-factor for the antioxidant enzymes Thioredoxin - reductase (TRR) and many other antioxidant enzymes, which protect tissues from oxidative stress. In septic patients it has previously been shown that thioredoxin, a TRR regulated Redox Enzyme, has the ability to suppress the synthesis of MIF.

Aim of the present study is therefore to investigate the relation between perioperative selenium decrease and the reduction of TRR activity with a possible release of MIF during the inflammatory response after cardiac surgery.

Study Timeline

• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-27
• Study First Posted: 2010-12-28
• Study Start: 2011-01
• Primary Completion: 2012-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• more than 18 years of age
• open heart surgery and use of heart-lung-device
• informed consent has been obtained

Exclusion Criteria

• under 18 years of age
• emergency cases
• informed consent cannot be obtained
• pregnancy or patient is breast-feeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Blood sampling	A single group of 100 consecutive patients will undergo additional blood sampling at different time points

Primary Outcome Measures

Name	Time	Method
Pilot study: correlation between clinical and lab parameters	two months	To assess the importance of the MIF ligand/receptor family in a large cohort of patients (n=100) undergoing cardiac surgery and to characterize the underlying molecular events.; Possible correlation between several clinical and laboratory parameters will be analyzed. This is a pilot study to generate hints at future items to be studied in controlled trials.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome	two months	* Correlation between perioperative MIF and MIF-2 levels and postoperative outcome; * Measurement of sCD74/MIF complex; * Determination of MIF polymorphism and its significance on clinical outcome; * perioperative inflammation; * organ injury

Trial Locations

Locations (1)

RWTH Aachen University Hospital; 🇩🇪 Aachen, NRW, Germany