Medical Education for Sepsis Source Control and Antibiotics (MEDUSA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Frank Bloos, Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier:
NCT01187134
First received: August 20, 2010
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Sepsis
Shock, Septic
Behavioral: Change Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Medical Education for Sepsis Source Control and Antibiotics

Resource links provided by NLM:


Further study details as provided by Center for Sepsis Control and Care, Germany:

Primary Outcome Measures:
  • All-cause mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fraction of patients with antimicrobial therapy within 1 hour [ Designated as safety issue: No ]
  • Duration until antimicrobial therapy [ Designated as safety issue: No ]
  • Duration until focus control [ Designated as safety issue: No ]
  • Frequency of blood cultures [ Designated as safety issue: No ]
  • Frequency of adequate antimicrobial therapy [ Designated as safety issue: No ]
  • ICU and hospital mortality [ Designated as safety issue: No ]
  • ICU and and hospital length of stay [ Designated as safety issue: No ]

Enrollment: 4138
Study Start Date: July 2011
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intervention group 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.
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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01187134

Locations
Germany
Universitätklinikum Aachen
Aachen, Germany
Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
Arnstadt, Germany
HELIOS Klinikum Aue
Aue, Germany
Zentralklinik Bad Berka GmbH
Bad Berka, Germany
Hufelandkrankenhaus GmbH
Bad Langensalza, Germany
Charité Berlin
Berlin, Germany
HELIOS Klinikum Emil von Behring
Berlin, Germany
HELIOS Kliniken Berlin-Buch
Berlin, Germany
Bundeswehrkrankenhaus Berlin
Berlin, Germany
Vivantes Klinikum Neukölln
Berlin, Germany
Ev. Krankenhaus Bielefeld
Bielefeld, Germany
HELIOS St. Josefs-Hospital Bochum-Linden
Bochum, Germany
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
St. Georg Klinikum Eisenach gGmbH
Eisenach, Germany
Waldkrankenhaus Rudolf Elle GmbH
Eisenberg, Germany
Katholisches Krankenhaus St. Johann Nepomuk
Erfurt, Germany
Helios Klinikum Erfurt
Erfurt, Germany
Bürgerhospital Friedberg
Friedberg, Germany
SRH Waldklinikum Gera
Gera, Germany
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, Germany
Klinik am Eichert
Göppingen, Germany
Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
Ilmenau, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsklinikum Kiel
Kiel, Germany
HELIOS-Klinikum Krefeld GmbH
Krefeld, Germany
Krankenhaus Landshut-Achdorf
Landshut, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Klinikum Meiningen GmbH
Meiningen, Germany
Saale-Unstrut-Klinikum Naumburg
Naumburg, Germany
Südharz-Krankenhaus Nordhausen gGmbH
Nordhausen, Germany
Klinikum Oldenburg
Oldenburg, Germany
Thüringen-Klinik Pößneck gGmbH
Pößneck, Germany
ASKLEPIOS-ASB Krankenhaus Radeberg GmbH
Radeberg, Germany
Thüringen-Kliniken "Georgius Agricola" GmbH
Saalfeld, Germany
Klinikum Saarbrücken gGmbH
Saarbrücken, Germany
Diakonie-Klinikum Schwäbisch-Hall gGmbH
Schwäbisch-Hall, Germany
Ev. Jung-Stilling-Krankenhaus
Siegen, Germany
SRH Zentralklinikum Suhl GmbH
Suhl, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Ulm
Ulm, Germany
Sophien- und Hufeland-Klinikum gGmbH
Weimar, Germany
HELIOS Klinikum Wuppertal
Wuppertal, Germany
Sponsors and Collaborators
Center for Sepsis Control and Care, Germany
Investigators
Principal Investigator: Reinhart Konrad, MD Jena University Hospital, Germany
Principal Investigator: Frank Bloos, MD, Ph.D. Jena University Hospital
  More Information

Additional Information:
Publications:

Responsible Party: Frank Bloos, Lead investigator of the MEDUSA study group, Center for Sepsis Control and Care, Germany
ClinicalTrials.gov Identifier: NCT01187134     History of Changes
Other Study ID Numbers: C1.1, 01EO1002, U1111-1118-2850
Study First Received: August 20, 2010
Last Updated: March 21, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Center for Sepsis Control and Care, Germany:
sepsis
shock, septic
quality assurance, health care
quality control
Survival Rate
Follow-Up Studies
Anti-Infective Agents/*therapeutic use

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Toxemia
Infection
Inflammation
Pathologic Processes
Shock
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on October 23, 2014