Trial document





This trial has been registered retrospectively.
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  DRKS00003490

Trial Description

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Title

Effects of procalcitonin-guided antimicrobial stewardship on reduction of antibiotical use in patients with severe sepsis or septic shock: a retrospective analysis.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Severe infection in Critical Care environment still remains a serious complication with high morbidity and mortality. An early start of antibiotic treatment has be convincingly shown to reduce mortality in critical ill patients. The development of antibiotic resistances of bacterial species, due to antibiotic overtreatment, has rendered indications and administration of available antibiotic substances as subject of reconsideration and discussion.
As a consequence of that, we implemented a Procalcitonin (laboratory marker for bacterial infection) guided algorithm.
This retrospective study analyse the effect of this program on antibiotic use in patients with severe life-threatening infection.

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Brief Summary in Scientific Language

Sepsis in ICU still remains a serious complication with high morbidity and mortality and considerably adds to health care expenses in intensive care medicine. An early start of antibiotic treatment has been convincingly shown to reduce mortality in critically ill patients. The development of antibiotic resistances of bacterial species, due to antibiotic overtreatment, has rendered indications and administration of available antibiotic substances as subject of reconsideration and discussion.
As a consequence of that, we implemented a procalcitonin (PCT)-algorithm to guide antibiotic treatment in severe infections which are know to be effective to reduce antibiotic use. This retrospective study analyses the effects of this program in clinical practice on antibiotical use in patients with severe sepsis and septic shock. Primary outcome parameters were: Lenght of ICU-Stay, 28-day mortality, Ventilation hours, Days on antibiotic therapy, ICU re-infection rate and mean antibiotic costs (per patient).

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Organizational Data

  •   DRKS00003490
  •   2012/02/08
  •   [---]*
  •   yes
  •   Approved
  •   D 409/10, Ethikkommission der Christian-Albrechts-Universität zu Kiel
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Secondary IDs

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

  •   A41.9 -  Septicaemia, unspecified
  •   R57.2 -  [generalization R57: Shock, not elsewhere classified]
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Interventions/Observational Groups

  •   Procalcitonin based algorithmen for tailoring antibiotictherapy.
    Retrospective analysis from 01.01.2005 to 31.12.2009
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Characteristics

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

Retrospective analyses
1. 28-day-Mortality
2. Days on Antibiotictherapy

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Secondary Outcome

1. Lenght of stay in Intensiv Care Unit 2. Ventilation hours 3. Re-infection rate 4. antibiotic cost

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2010/05/01
  •   150
  •   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

Severe sepsis and septic shock under antibiotic therapy

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Exclusion Criteria

known pregnancy; bone-marrow transplant or patient under chemotherapy; infections for which long-term antibiotic treatment is strongly recommended (e.g. infective endocarditis, tuberculosis, anterior mediastinitis after cardiac surgery) and do- not-resuscitate orders

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Addresses

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    • Klinik für Anästhesiologie , operative Intensivmedizin und Schmerztherapie Krankenhaus Düren
    • Mr.  Prof. Dr. med  Stefan  Schröder 
    • Roonstrasse 30
    • 52351  Düren
    • Germany
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    • Klinik für Anästhesiologie, Intensiv-, Palliativ und Schmerzmedizin Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
    • Mr.  Andreas  Hohn 
    • Bürkle-de-la-Camp-Platz 1
    • 44789   Bochum
    • Germany
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    • Klinik für Anästhesiologie der Universität Heidelberg
    • Mr.  Dr. med.  Marcel  Hochreiter 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Westküstenklinikum Heide
    • Esmarchstarssse 50
    • 25746  Heide
    • Germany
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    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2011/12/15
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Trial Publications, Results and other Documents

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