Trial document




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  DRKS00009850

Trial Description

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Title

Evalulation of Neutrophil Extracellular Traps (NETs) as prognostic markers after elective cardiac surgery

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Systemic inflammation (SIRS) is a common response in critically ill patients and a known side-effect after surgery. Especially in cardiac surgery with cardiopulmonary bypass (CPB) SIRS is a well described phenomenon. Perioperative complications are associated with an increased risk for the development of organ dysfunction as well as increased morbidity and mortality after cardiac surgeries. The prevalence of SIRS is very high, affecting one-third of all in-hospital patients, and >50% of all ICU patients; in surgical ICU patients, SIRS occurs in >80% patients. It is widely recognized that CPB surgery and in particular contact with the foreign surfaces induce inflammatory reactions that can culminate in coagulopathies and organ dysfunctions. Polymorphonuclear neutrophils (PMN) are the most abundant terminally differentiated white blood cells in humans. In addition to their crucial role in protecting against infection, recent evidence suggests that PMN also might modulate both, innate and adaptive immune responses. PMN are the first cells to migrate to sites of infection or sterile inflammation, where they become activated to perform several tasks, including cytokine production, degranulation and phagocytosis. In 2004, Brinkman et al. have described the release of „neutrophil extracellular traps” (NETs), a process termed NETosis. The NETs scaffold consists of filaments of decondensed chromatin associated with granular proteins that can entrap pathogens but also contribute to the pathophysiology of multiple inflammatory diseases such as stroke, myocardial ischemia / reperfusion injury, thrombosis and sepsis. Actually, inappropriate NETs release may cause tissue damage and inflammation. In this context, recent studies suggested that NETs-associated proteins such as myeloperoxidase and histones are responsible for NETs-mediated endothelial and epithelial cell cytotoxicity. Here, we aim to elucidate the role of NETs as prognostic markers for perioperative complications after CPB cardiac surgery. Patients undergoing bypass surgery without CPB will serve as control. NETs will be quantified in patients‘ plasma at defined time points before and after surgery. In addition, NETs levels will be correlated with patients‘ clinical scores and neutrophil apoptosis rate. These data will reveal whether NETs might be used as biomarkers predicting the development of perioperative SIRS-mediated complications, which might help to identify high-risk patients.

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Organizational Data

  •   DRKS00009850
  •   2016/04/04
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  •   yes
  •   Approved
  •   16-004, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1180-8824 
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Health Condition or Problem studied

  •   SIRS -(systemic inflammatory Response Syndrome) and development of complications, such as Sepsis, after cardiac surgery
  •   R65 -  Systemic Inflammatory Response Syndrome [SIRS]
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Interventions/Observational Groups

  •   Patients undergoing off pump coronary artery Bypass (OPCAB) surgery will serve as control. NETs Level in the control group will be compared to those measured in patients undergoing cardiopulmonary Bypass (CPB) (2nd and 3rd Group), which develop SIRS.
  •   valve replacement + CPB
  •  
    valve replacement + Bypass + CPB
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Historical
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Blood samples will be collected from patients undergoing cardiac surgery at the day of admission, pre-OP, post-OP as well as at days 1, 3,, 5, 8 and 10 after surgery. NETs levels in patients' Plasma will be quantified by photometry and Real Time PCR, respectively.

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Secondary Outcome

The scoring Systems CASUS, SOFA and APACHEII will be calculated. Plasma NETs level will be correlated to patients' scores

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2016/04/04
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Written informed consent from all participants or their legal representatives

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Exclusion Criteria

- patients with known preexisting immunological disorders or systemic immunosuppressive medication
-no consent
-<18

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Addresses

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    • Herzzentrum der Universität zu KölnKlinik für Herz- und Thoraxchirurgie
    • Ms.  Dr.  Adnana  Paunel-Görgülü 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Herzzentrum der Universität zu KölnKlinik für Herz- und Thoraxchirurgie
    • Ms.  Dr.  Adnana  Paunel-Görgülü 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Herzzentrum der Universität zu Köln
    • Ms.  Dr  Adnana  Paunel-Görgülü 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Herzzentrum der Universität zu Köln
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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