Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01267721
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : October 8, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Heart Surgery Procedure: Blood sampling

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 Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Macrophage Migration Inhibitory Factor (MIF) as a Marker of Perioperative Inflammatory Reaction During Heart Surgery
Study Start Date : January 2011
Actual Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Study Group
A single group of 100 consecutive patients will undergo additional blood sampling at different time points
Procedure: Blood sampling
Blood sampling at various time points. Additional 92 mL blood.

Primary Outcome Measures :
  1. Pilot study: correlation between clinical and lab parameters [ Time Frame: 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 :
  1. Secondary Outcome [ Time Frame: 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

Biospecimen Retention:   Samples Without DNA
inflammatory markers (different)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing open heart surgery and use of heart lung device

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01267721

RWTH Aachen University Hospital
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Principal Investigator: Steffen Rex, PD Dr. med. RWTH Aachen University Hospital

Responsible Party: RWTH Aachen University Identifier: NCT01267721     History of Changes
Other Study ID Numbers: CTC-A10-029
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: October 8, 2014
Last Verified: October 2014

Keywords provided by RWTH Aachen University:
heart surgery