Trial document




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  DRKS00005046

Trial Description

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Title

Determination of antibiotic concentrations in interstitial space fluid of muscle and subcutis in septic patients including a pilot phase

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Trial Acronym

DAC-septic patient

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To evaluate feasibility of antibiotic concentration determination in interstitial space fluid of muscle and subcutis in septic patients including a pilot phase to explore pharmacokinetic variability and to determine sample size for the main study.

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Brief Summary in Scientific Language

To evaluate feasibility of antibiotic concentration determination in interstitial space fluid of muscle and subcutis in septic patients including a pilot phase to explore pharmacokinetic variability and to determine sample size for the main study.

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Organizational Data

  •   DRKS00005046
  •   2013/07/09
  •   [---]*
  •   yes
  •   Approved
  •   11-4691 , Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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

  •   A41.9 -  Sepsis, unspecified
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Interventions/Observational Groups

  •   Tissue concentrations of antibiotic were obtained by microdialysis and analysed with HPLC during the 1 - 4 day. Since both are different in sepsis, the protein binding and the distribution of water volume as a function of stage of sepsis, the antibiotics effective concentrations during sepsis should be different. This study investigated the hypothese that the tissue concentration of antibiotics during sepsis ist below the MHK. Therefore be measured in this study, whether the antibiotics are adequate dosage during different phases of sepsis.




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Characteristics

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

Area under the concentration time curve (AUC), maximum concentration (Cmax), half-life (t1/2) in the microdialysate and plasma after single dose and at steady state.

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Secondary Outcome

Assoziation of 30 days survival in patients withe sepsis dependent on tussues concentrations of antibiotics. Plasma will be revieled with microdialysis and analysed with HPLC.

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Countries of Recruitment

  •   Germany
  •   Austria
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Locations of Recruitment

  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/11/30
  •   20
  •   Multicenter trial
  •   International
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Inclusion Criteria

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

Severe sepsis or septic shock as diagnosed according to the criteria of ACCP/SCCM and the MAXSEP Study within 24 hours:

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Exclusion Criteria

Age < 18 years

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Addresses

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    • Knappschaftskrankenhaus Bochum Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
    • Mr.  Prof. Dr. med.  Michael  Adamzik 
    • In der Schornau 23-25
    • 44892  Bochum
    • Germany
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    • Knappschaftskrankenhaus Bochum Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
    • Mr.  Prof. Dr. med.  Michael  Adamzik 
    • In der Schornau 23-25
    • 44892  Bochum
    • Germany
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    • Knappschaftskrankenhaus Bochum Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie
    • Mr.  Prof. Dr. med.  Michael  Adamzik 
    • In der Schornau 23-25
    • 44892  Bochum
    • Germany
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Sources of Monetary or Material Support

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    • Paul-Ehrlich-Stiftung c/o Deutsche Bank AG
    • Taunusanlage 17
    • 60325  Frankfurt am Main
    • 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.