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Completed

NCT Number: NCT01267721

Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery

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.

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Key information

Conditions

Heart Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sampling

Procedure

Blood sampling at various time points. Additional 92 mL blood.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

RWTH Aachen University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
First posted
Dec 28, 2010
Registry last updated
Oct 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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