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Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT01267721
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

December 22, 2010
December 28, 2010
October 8, 2014
January 2011
December 2012   (Final data collection date for primary outcome measure)
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.
Pilot study: correlation between clinical and lab parameters [ Time Frame: two months ]
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.
Complete list of historical versions of study NCT01267721 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
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Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery
Macrophage Migration Inhibitory Factor (MIF) as a Marker of Perioperative Inflammatory Reaction During Heart 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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
inflammatory markers (different)
Non-Probability Sample
Patients undergoing open heart surgery and use of heart lung device
Heart Surgery
Procedure: Blood sampling
Blood sampling at various time points. Additional 92 mL blood.
Study Group
A single group of 100 consecutive patients will undergo additional blood sampling at different time points
Intervention: Procedure: Blood sampling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
Same as current
Not Provided
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01267721
CTC-A10-029
No
Not Provided
Not Provided
RWTH Aachen University
RWTH Aachen University
Not Provided
Principal Investigator: Steffen Rex, PD Dr. med. RWTH Aachen University Hospital
RWTH Aachen University
October 2014