Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery

Heart Surgery Clinical Trial

Official title:

Macrophage Migration Inhibitory Factor (MIF) as a Marker of Perioperative Inflammatory Reaction During Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267721
• Other study ID #: CTC-A10-029
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: October 7, 2014
• Start date: January 2011

Study information

• Verified date: October 2014
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Insitute for Drugs and Medicinal Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Surgery

Intervention

Procedure:
• Blood sampling
Blood sampling at various time points. Additional 92 mL blood.

Locations

Country	Name	City	State
Germany	RWTH Aachen University Hospital	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pilot study: correlation between clinical and lab parameters	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.	two months	Yes
Secondary	Secondary Outcome	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	two months	Yes