Trial document




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  DRKS00006265

Trial Description

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Title

Spectroscopic differentiation of leukocytes and their activation patterns as a rapid diagnostic tool of systemic inflammation and sepsis

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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

The study aims at the validation of the capacity of Raman spectroscopy in isolated leukocyte subpopulations (e.g. granulocytes, lymphocytes) to discriminate the severity grade of systemic inflammatory responses and sepsis, thus providing the basis for a reliable rapid diagnostic tool. The identification of spectroscopic profiles reflecting differential degrees of leukocyte activation would permit their implication as diagnostic biomarkers. The validity of spectroscopic profiles will be examined by comparisons with established inflammatory biomarkers, such as CRP, PCT and IL-6. Subsequent data analysis will result in elaboration of a receiver-operating characteristics (ROC) classification paradigm for rapid sepsis diagnostics.

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Organizational Data

  •   DRKS00006265
  •   2014/06/25
  •   [---]*
  •   yes
  •   Approved
  •   4004-02/14, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   R65.0 -  Systemic Inflammatory Response Syndrome of infectious origin without organ failure
  •   R65.1 -  Systemic Inflammatory Response Syndrome of infectious origin with organ failure
  •   R65.2 -  Systemic Inflammatory Response Syndrome of non-infectious origin without organ failure
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Interventions/Observational Groups

  •   Patients with severe sepsis/septic shock and manifest signs of organ failure (Raman spectroscopy in isolated leukocytes and determination of serum levels of CRP, PCT and IL-6)
  •   Patients diagnosed with sepsis without signs of organ failure (Raman spectroscopy in isolated leukocytes and determination of serum levels of CRP, PCT and IL-6)
  •   Patients diagnosed with an active infection showing not more than one sign of systemic inflammatory response syndrome (SIRS) (Raman spectroscopy in isolated leukocytes and determination of serum levels of CRP, PCT and IL-6)
  •   Patients showing at least one sign of systemic inflammatory response syndrome, however, without a co-present infection (Raman spectroscopy in isolated leukocytes and determination of serum levels of CRP, PCT and IL-6)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Diagnostic sensitivity and specifity of leukocyte Raman spectra

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Secondary Outcome

none

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/26
  •   108
  •   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

1. Presence of at least one clinical sign of SIRS; 2. Signed informed consent

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Exclusion Criteria

1. HIV infection; 2. Current glucocorticoid treatment at doses above the Cushing threshold; 3. Malignancy; 4. Neutropenia of non-infectios origin; 5. Immune deficiency of non-infectious origin

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Addresses

  • start of 1:1-Block address primary-sponsor
    • IFB Sepsis und Sepsisfolgen (CSCC)Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Michael  Bauer 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • IFB Sepsis und Sepsisfolgen (CSCC)Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Michael  Bauer 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • IFB Sepsis und Sepsisfolgen (CSCC)Universitätsklinikum Jena
    • Ms.  Dr.  Ute  Neugebauer 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • IFB Sepsis und Sepsisfolgen (CSCC)Universitätsklinikum Jena
    • Mr.  Prof. Dr. med.  Michael  Bauer 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • IFB Sepsis und Sepsisfolgen (CSCC)Universitätsklinikum Jena
    • Mr.  Prof. Dr.  Michael  Bauer 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Neugebauer U et al. J Biophotonics 2014, 7: 232-240
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* This entry means the parameter is not applicable or has not been set.