Trial document




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  DRKS00008550

Trial Description

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Title

Examination of predictive parameters for early diagnosis and therapy of organ failure in patients with 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

Therefore this single-centre study aimed at investigating the effect of differentially regulated proteins in the blood and urine for early diagnosis of acute organ failure in patients with sepsis.
The urine and blood samples will then be examined with molecular biological techniques (Proteomics).

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Organizational Data

  •   DRKS00008550
  •   2015/07/02
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  •   yes
  •   Pending/not yet approved
  •   15-104, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

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Health Condition or Problem studied

  •   A41.9 -  Sepsis, unspecified
  •   R57.2 -  Septic shock
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Interventions/Observational Groups

  •   60 patients will be enrolled in this study. In these patients samples of blood und urine are taken once daily during a period of 20 days.
    The urine and blood samples will then be examined with molecular biological techniques (Proteomics).
    The protein are separated by standard agarose gel electrophoresis. The protein identification becomes possible by mass spectroscopy.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Early detection of organ failure in patients with sepsis.

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Secondary Outcome

The initiation and maintenance of renal replacement therapy.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2015/07/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Patients with sepsis in accordance with the criteria of the German Sepsis Society.

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Exclusion Criteria

Patientes with dialysis-dependent kidney insufficiency
Pregnancy

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Addresses

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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Priv.-Doz. Dr. med.  Jochen  Hinkelbein 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Klinik für Kardiologie, Angiologie, Pneumologie und internistische Intensivmedizin.
    • Mr.  Dr. med.  Christoph  Adler 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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  • start of 1:1-Block address scientific-contact
    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Priv.-Doz. Dr. med.  Jochen  Hinkelbein 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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    • Klinik für Anästhesiologie und Operative Intensivmedizin
    • Mr.  Priv.-Doz. Dr. med.  Jochen  Hinkelbein 
    • Kerpenerstr. 62
    • 50937  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln
    • Mr. 
    • Kerpenerstr. 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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* This entry means the parameter is not applicable or has not been set.