Trial document




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  DRKS00008855

Trial Description

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Title

Influence of a minimized extracorporeal circulation on angiopoietin-1 and -2, and other markers of endothelial activation, a diagnostic study

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Trial Acronym

/

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URL of the Trial

http:///

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Brief Summary in Lay Language

In open-heart surgery patients need to be temporarily connected to a heart-lung machine, to ensure the circulation of the body. The contact of the patient's blood with the surfaces of the heart-lung machine leads to an activation of the body's inflammatory system with some potential side effects. There are for bypass surgery basically three methods:
1. normal hours of cardiopulmonary bypass,
2. a mini cardiopulmonary bypass and
3. surgery on the beating heart without the use of cardiopulmonary bypass.
Which of the three methods is applied, it decides on an individual, regardless of the study.
On the basis of operational data and blood samples, the surgical procedures are to be compared. With the targeted investigation of certain proteins that have a decisive influence on the recovery after such surgery, new insights into the predictability of complications after surgery with a connection to be gained in the cardiopulmonary bypass.

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Brief Summary in Scientific Language

In applying a conventional cardiopulmonary bypass (CPB), there is an endothelial activation. Angiopoietin-2 was identified as a possible mediator of CPB-induced endothelial barrier dysfunction. Minimized extracorporeal perfusion systems (so-called. Minimized Perfusion Circuit, MPC) appear against CPB to have advantages in terms of organ dysfunction, but it is unclear whether MPC and the surgery without extracorporeal circulation (off-pump) are associated with reduced endothelial markers.
It is believed that Angiopoietin-2 (Angpt-2) and other markers of endothelial activation by MPC or off-pump surgery (OPCAB) in comparison with conventional CPB is reduced.
The aim of the prospective diagnostic study is the characterization of endothelial activation and the capillary leak by measuring of angiopoietin-1 and -2 (and possibly other Inflammationsparametern) by ELISA as well as the comparative analysis of the parameters collected for significant differences between the groups CPB, OPCAB and MPC.

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Organizational Data

  •   DRKS00008855
  •   2015/06/25
  •   [---]*
  •   yes
  •   Approved
  •   51/15, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1171-2959 
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Health Condition or Problem studied

  •   I25.13 -  [generalization I25.1: Atherosclerotic heart disease]
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Interventions/Observational Groups

  •   In patients with the need for coronary bypass surgery EDTA blood (plasma) is taken at the following times:
    a. before connecting to the extracorporeal circulation (after opening the pericardium during OPCAB)
    b. following the departure of the extracorporeal circulation,
    c. 24 hours after departure from extracorporeal circulation and
    d. 72h after disposal of extracorporeal circulation.

    The samples are stored at -80 ° C and there is a measure of angiopoietin-1 and -2 (and possibly other inflammatory marker) by ELISA to an evaluation of the parameters collected for significant differences between the groups CPB, OPCAB and MPC.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Diagnosis of angiopoietin-1 and -2 as well as other inflammatory and endothelial marker

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Secondary Outcome

- Vital and laboratory values of the first 72h
- fluid balance of the first 72 hours
- Katecholamindosen the first 72h
- organ dysfunction (Sequential Organ Failure Assessment [SOFA] and other scores)
- consumption of blood products
- hospital stays and intensive care hospital
- survival
- Quality of Life

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2015/08/06
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Coronary of extracorporeal circulation
- Age> 18 years
- Written consent

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Exclusion Criteria

- Pre-existing rheumatic or chronic infectious disease (such as systemic lupus erythematosus, ANCA-positive vasculitis, rheumatoid arthritis, etc.)
- Certain medications (cortisol, immunosuppressants, ongoing oncological therapy)
- major surgery in the last 3 months
- renal insufficiency stage 3 or higher (GFR <60ml / min)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsklinik für Herz- und Thoraxchirurgie
    • Mr.  Prof. Dr. med.  Ingo  Kutschka 
    • Leipziger Str. 44
    • 39112  Magdeburg
    • Germany
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    • Universitätsklinikum MünsterMedizinische Klinik D
    • Mr.  PD Dr. med.  Phillipp  Kümpers 
    • Albert-Schweizer-Campus 1, Gebäude A.1
    • 48149  Münster
    • Germany
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    • Universitätsklinikum MünsterMedizinische Klinik D
    • Mr.  Dr. med.  Alexander-Henrik  Lukasz 
    • Albert-Schweizer-Campus 1, Gebäude A.1
    • 48149  Münster
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Universitätsklinik für Herz- und Thoraxchirurgie
    • Mr.  Dr. med.  Johannes  Hadem 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Herz- und Thoraxchirurgie
    • Mr.  Dr. med.  Johannes  Hadem 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Herz- und Thoraxchirurgie
    • Mr.  Prof. Dr. med.  Ingo  Kutschka 
    • Leipziger Str. 44
    • 39112  Magdeburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/09/30
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.