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Macrophage Migration Inhibitory Factor (MIF)- Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01267721
First received: December 22, 2010
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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 Intervention
Heart Surgery
Procedure: Blood sampling

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Macrophage Migration Inhibitory Factor (MIF) as a Marker of Perioperative Inflammatory Reaction During Heart Surgery

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Pilot study: correlation between clinical and lab parameters [ Time Frame: two months ] [ Designated as safety issue: Yes ]

    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:
  • Secondary Outcome [ Time Frame: two months ] [ Designated as safety issue: Yes ]
    • 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)


Enrollment: 100
Study Start Date: January 2011
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing open heart surgery and use of heart lung device

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01267721

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

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01267721     History of Changes
Other Study ID Numbers: CTC-A10-029
Study First Received: December 22, 2010
Last Updated: October 7, 2014
Health Authority: Germany: Federal Insitute for Drugs and Medicinal Devices

Keywords provided by RWTH Aachen University:
heart surgery

ClinicalTrials.gov processed this record on November 25, 2014