Trial document




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  DRKS00005420

Trial Description

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Title

Microdialysis application for determination of cytokines in healthy volunteers

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Trial Acronym

KP-Cyt04

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Cytokines are important mediators of every kind of immune response of the human organismen. Consequently cytokines play an important role in development, status and cure of various diseases like infections.
The microdialysis technique was developed to determine physiological analytes directly from the tissue of interest. Furthermore microdialysis application was broaden to investigate drug concentrations in different tissues.
This study aims to apply this technique for the determination of cytokines directly from the tissue of healthy volunteers.

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Brief Summary in Scientific Language

Cytokines are important mediators of immune responses of the human organismen. Consequently cytokines play an important role in development, status and cure of various diseases like infections.
The microdialysis technique was developed to determine physiological analytes (e.g. neutrotransmitors, catabolic substances) directly from the interstitial fluid (ISF) of the investigated tissue. Furthermore microdialysis application was broaden to investigate drug concentrations in the ISF of the target tissues.
This study aims to apply this technique for the determination of cytokines directly from the ISF of the abdominal subcutanous tissue.

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Organizational Data

  •   DRKS00005420
  •   2013/11/12
  •   [---]*
  •   yes
  •   Approved
  •   EA4/098/13, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   healthy volunteers
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Interventions/Observational Groups

  •   long-term microdialysis of cytokines in the abdominal subcutaneous tissue over 3 days
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Quantifiability of cytokine concentrations from microdialysate

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Secondary Outcome

- dependence of cytokine concentrations on flow rate
- feasibility of determination of the relative recovery and subsequent quantification of interstitial fluid concentrations
- monitoring of cytokine concentrations over time

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2013/11/11
  •   4
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   25   Years
  •   40   Years
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Additional Inclusion Criteria

- BMI 18.5-30 kg/m2
- normal findings at screening

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Exclusion Criteria

- chronic medical intervention
- pregnancy and breatfeeding
- irritations at the abdominal skin
- concurrent participation in other studies

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Addresses

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    • Freie Universität Berlin, Abteilung Klinische Pharmazie und Biochemie
    • Ms.  Prof. Dr.  Charlotte  Kloft 
    • Kelchstr. 31
    • 12169  Berlin
    • Germany
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    • Klinik für Anaesthesiologie und operative Intensivmedizin, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin
    • Mr.  Dr.  Martin  Kees 
    • Hindenburgdamm 30
    • 12200  Berlin
    • Germany
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    • Freie Universität Berlin, Abteilung Klinische Pharmazie und Biochemie
    • Ms.  Claudia  Kirbs 
    • Kelchstr. 31
    • 12169  Berlin
    • Germany
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    • Freie Universität Berlin, Abteilung Klinische Pharmazie und Biochemie
    • Ms.  Claudia  Kirbs 
    • Kelchstr. 31
    • 12169  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Freie Universität BerlinAbteilung Klinische Pharmazie und Biochemie
    • Ms.  Prof. Dr.  Charlotte  Kloft 
    • Kelchstr. 31
    • 12169  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2013/11/28
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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.