Trial document





This trial has been registered retrospectively.
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  DRKS00004948

Trial Description

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Title

ABx-Children – Utilisation of Standard Operating Procedures (SOPs) in the anti-infective therapy on a pediatric intensive care unit.

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Meanwhile the utilisation of standardised procedure instructions is an inherent part in the intensive care medicine. A number of studies have shown that the adherence to these procedure instructions has a positive effect on the course of the disease of adult patients. The aim of this study is to show if the usage of the SOPs grant the children and adolescent the same effects. Furthermore an existing computer programme with standardised procedure instructions for intensive care patients shall be expanded by a module for children with the help of the collected data.

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Brief Summary in Scientific Language

With the help of this retrospective cohort study of the patient cases of the years 2009/10 on a pediatric intensive care unit it shall be analysed if the adherence to Standard Operating Procedures of the anti-infective therapy is associated with a positive effect on the outcome of the pediatric patients.

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Organizational Data

  •   DRKS00004948
  •   2013/06/04
  •   [---]*
  •   yes
  •   Approved
  •   EA1/053/11, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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

  •   Infectious diseases
  •   A00-B99 -  Certain infectious and parasitic diseases
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Interventions/Observational Groups

  •   The patient cases (age of the patients <18 y) of the years 2009/10 on a pediatric intensive care unit where the patients were treated with antibiotics and/or had an evidence of an bacterial infection. It shall be analysed if a high adherence to Standard Operating Procedures (SOPs) at the antiinfective therapy is positively associated with the outcome of the patients on pediatric intensive care units.
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Characteristics

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

SOP Adherence: congruence rate between the recommendation and observed therapy measured at the end of the ICU stay.

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Secondary Outcome

Length of stay in hospital, length of stay on ICU, mortality, duration of mechanical ventilation, duration of antibiotic therapy, administered antibiotics per day, appereance of organ dysfunctions.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/04/04
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   4   Weeks
  •   18   Years
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Additional Inclusion Criteria

Age <18 years, antibiotic therapy and/or evidence of bacterial infection, length of ICU-stay >24h

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Exclusion Criteria

Neither anti-infective therapy nor evidence of bacterial infection, length of ICU-stay < 24h

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Addresses

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    • Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin Campus Charité Mitte und Campus Virchow-Klinikum Charité – Universitätsmedizin Berlin
    • Ms.  Univ.-Prof. Dr. med.  Claudia  Spies 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    • Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin Campus Charité Mitte und Campus Virchow-Klinikum Charité – Universitätsmedizin Berlin
    • Ms.  Univ.-Prof. Dr. med.  Claudia  Spies 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin Campus Charité Mitte und Campus Virchow-Klinikum Charité – Universitätsmedizin Berlin
    • Ms.  Univ.-Prof. Dr. med.  Claudia  Spies 
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Charité Campus Virchow-Klinikum
    • Augustenburger Platz 1
    • 13353  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/04/02
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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.