Medical Education for Sepsis Source Control and Antibiotics (MEDUSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01187134
Recruitment Status : Completed
First Posted : August 23, 2010
Last Update Posted : August 9, 2017
Information provided by (Responsible Party):
Frank Bloos, Center for Sepsis Control and Care, Germany

August 20, 2010
August 23, 2010
August 9, 2017
July 2011
June 2013   (Final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT01187134 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
Medical Education for Sepsis Source Control and Antibiotics
Medical Education for Sepsis Source Control and Antibiotics

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.

This study is a cluster randomized trial (CRT) where the hospitals are the clusters. 44 hospitals in Germany have confirmed their participation. 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 CRT was preceded by a 5 months observational study (Dec. 2010 - April 2011). In about 1000 patients, participating hospitals documented their patients with severe sepsis or septic shock into a register. These data are used for final 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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Sepsis
  • Shock, Septic
Behavioral: Change Management
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.
  • Active Comparator: Intervention group
    Intervention: Behavioral: Change Management
  • No Intervention: Conventional CME
    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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2013
June 2013   (Final data collection date for primary outcome measure)

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:

      1. Prehospital
      2. Emergency department
      3. Operating theatre
      4. Regular ward
      5. Intensive care unit (ICU)/Intermediate Care Unit (IMC)

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)
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
01EO1002 ( Other Grant/Funding Number: Federal Ministry of Education and Research (BMBF) of Germany )
U1111-1118-2850 ( Other Identifier: WHO Universal Trial Number )
Not Provided
Not Provided
Frank Bloos, Center for Sepsis Control and Care, Germany
Center for Sepsis Control and Care, Germany
Not Provided
Principal Investigator: Reinhart Konrad, MD Jena University Hospital, Germany
Principal Investigator: Frank Bloos, MD, Ph.D. Jena University Hospital
Center for Sepsis Control and Care, Germany
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP