Trial document




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  DRKS00000621

Trial Description

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Title

Medical Education for Sepsis Source Control and Antibiotics

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Trial Acronym

MEDUSA

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URL of the Trial

http://www.medusa.uniklinikum-jena.de

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Brief Summary in Lay Language

Patients with severe sepsis or septic shock suffer from life-threatening infections. Fast and adequate therapy with antibiotics is crucial for survival. Current guidelines recommend the application of broad-spectrum antibiotics within 1 hour after diagnosis. However, recent studies showed that such treatment is delayed for several hours.

In this study, medical staff of participating hospitals is trained to achieve a duration until antimicrobial therapy of less than 1 hour. Tools of change management are used. The data are compared to a control group (hospitals without intervention).

It is hypothesized that a multifaceted educational program decreases duration until antimicrobial therapy and improves survival.

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Brief Summary in Scientific Language

This study is a cluster randomized trial (CRT) where the hospitals are the clusters. 44 hospitals in Germany are participating. Hospitals are randomized into two groups: a control and an interventional group. The control group receives conventional CMEs. The interventional group receives tools for increasing awareness such as posters and brochures. Quality measure such as benchmarking and feedback of quality indicators are used. Depending on the improvement process tools such as SWOT analyses and resistance radar will be implemented. The control group receives conventional CME lectures about sepsis and infection management.

The CRT was preceded by a 5 months observational study from Dec. 2010 - April 2011. The hospitals documented about 1000 patients with severe sepsis or septic shock into a register. These data are used for sample size calculation of the CRT and for stratification of the randomization.

The groups switch after completion of the CRT and observation continues. Thus, centers of the control group now receive the change management while the former intervention group is now without external support and is assessed for sustainability of the intervention. This study phase is planned for Nov. 2013 until March 2015. Sample size will be calculated when the CRT has been finished.

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Organizational Data

  •   DRKS00000621
  •   2010/11/25
  •   2010/08/20
  •   yes
  •   Approved
  •   2910-08/10, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   U1111-1118-2850 
  •   NCT01187134  (ClinicalTrials.gov)
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Health Condition or Problem studied

  •   A41 -  Other septicaemia
  •   Severe Sepsis
  •   Septic Shock
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Interventions/Observational Groups

  •   Control group:
    Hospitals receive conventional continuing medical education in lecture style twice a year. They receive current publications and recommendations for national and international meetings regarding diagnosis and therapy of sepsis.
  •   Intervention group:
    Hospitals have to create local change teams which are supported and trained by the study center. Local awareness of the staff is increased by PowerPoint presentations, posters, and brochures. The change teams receive monthly information about their quality indicator (duration until antimicrobial therapy). Anonymous comparison to other hospitals is possible (Benchmarking). Hospitals are visited three times a year to discuss progress of quality. In case of failure to improve, the change team is supported with specific tools for change management such as SWOT-analysis or resistance radar.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

28 days all-cause mortality

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Secondary Outcome

Fraction of patients with antimicrobial therapy within 1 hour
Duration until antimicrobial therapy
Duration until focus control
Frequency of blood cultures
Frequency of adequate antimicrobial therapy
ICU and hospital mortality
ICU and and hospital length of stay

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/07/01
  •   2000
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

1. For the hospitals (cluster):
- Involved in the primary care of patients with severe sepsis/septic shock
- Willing to participate in a guideline implementation process

2. For the patients:
- New onset of suspicion of severe sepsis or septic shock in the following settings:
a. Prehospital
b. Emergency department
c. Operating theatre
d. Regular ward
e. Intensive care unit (ICU)/Intermediate Care Unit (IMC)

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Exclusion Criteria

1. For the hospitals (cluster):

- No intensive care unit available
- no acute care for patients with severe sepsis and septic shock

2. For the patients:
- Start of sepsis therapy in a non-study site
- Patients not admitted to the ICU/IMC
- No commitment to full medical support (i.e. DNR)

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Addresses

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    • Jena University Hospital Center for Sepsis Control & Care
    • Mr.  Prof. Dr. med.  Konrad  Reinhart 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Jena University Hospital Center for Sepsis Control & Care
    • Mr.  Dr. med.  Frank  Bloos 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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    • Jena University Hospital Center for Sepsis Control & Care
    • Mr.  Dr. med.  Frank  Bloos 
    • Erlanger Allee 101
    • 07747  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF)
    • 10115  Berlin
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/07/30
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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.