- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01267721
Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery
Macrophage Migration Inhibitory Factor (MIF) as a Marker of Perioperative Inflammatory Reaction During Heart Surgery
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
NRW
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Aachen, NRW, Germany, 52074
- RWTH Aachen University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Study Group
A single group of 100 consecutive patients will undergo additional blood sampling at different time points
|
Blood sampling at various time points.
Additional 92 mL blood.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Outcome
Time Frame: two months
|
|
two months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Steffen Rex, PD Dr. med., RWTH Aachen University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CTC-A10-029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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