Medical Education for Sepsis Source Control and Antibiotics

Not Applicable

Completed

• Conditions: Shock, Septic; Sepsis
• Interventions: Behavioral: Change Management

• Registration Number: NCT01187134
• Lead Sponsor: Center for Sepsis Control and Care, Germany

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-20
• Study First Posted: 2010-08-23
• Study Start: 2011-07
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4138

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Change Management	-

Primary Outcome Measures

Name	Time	Method
All-cause mortality	28 days

Secondary Outcome Measures

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

Trial Locations

Locations (41)

Universitätsklinikum Ulm; 🇩🇪 Ulm, Germany

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

HELIOS Klinikum Wuppertal; 🇩🇪 Wuppertal, Germany

Sophien- und Hufeland-Klinikum gGmbH; 🇩🇪 Weimar, Germany

Universitätsklinikum Carl Gustav Carus; 🇩🇪 Dresden, Germany

Katholisches Krankenhaus St. Johann Nepomuk; 🇩🇪 Erfurt, Germany

St. Georg Klinikum Eisenach gGmbH; 🇩🇪 Eisenach, Germany

Helios Klinikum Erfurt; 🇩🇪 Erfurt, Germany

Universitätklinikum Aachen; 🇩🇪 Aachen, Germany

Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH; 🇩🇪 Ilmenau, Germany

HELIOS Klinikum Aue; 🇩🇪 Aue, Germany

Zentralklinik Bad Berka GmbH; 🇩🇪 Bad Berka, Germany

Hufelandkrankenhaus GmbH; 🇩🇪 Bad Langensalza, Germany

Bundeswehrkrankenhaus Berlin; 🇩🇪 Berlin, Germany

HELIOS Klinikum Emil von Behring; 🇩🇪 Berlin, Germany

Vivantes Klinikum Neukölln; 🇩🇪 Berlin, Germany

HELIOS St. Josefs-Hospital Bochum-Linden; 🇩🇪 Bochum, Germany

Ernst-Moritz-Arndt-Universität Greifswald; 🇩🇪 Greifswald, 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

Thüringen-Klinik Pößneck gGmbH; 🇩🇪 Pößneck, Germany

Thüringen-Kliniken "Georgius Agricola" GmbH; 🇩🇪 Saalfeld, Germany

ASKLEPIOS-ASB Krankenhaus Radeberg GmbH; 🇩🇪 Radeberg, Germany

Ev. Jung-Stilling-Krankenhaus; 🇩🇪 Siegen, Germany

Diakonie-Klinikum Schwäbisch-Hall gGmbH; 🇩🇪 Schwäbisch-Hall, Germany

HELIOS Kliniken Berlin-Buch; 🇩🇪 Berlin, Germany

Ev. Krankenhaus Bielefeld; 🇩🇪 Bielefeld, Germany

Waldkrankenhaus Rudolf Elle GmbH; 🇩🇪 Eisenberg, Germany

SRH Waldklinikum Gera; 🇩🇪 Gera, Germany

Klinik am Eichert; 🇩🇪 Göppingen, Germany

Bürgerhospital Friedberg; 🇩🇪 Friedberg, Germany

Südharz-Krankenhaus Nordhausen gGmbH; 🇩🇪 Nordhausen, Germany

Klinikum Oldenburg; 🇩🇪 Oldenburg, Germany

Klinikum Saarbrücken gGmbH; 🇩🇪 Saarbrücken, Germany

SRH Zentralklinikum Suhl GmbH; 🇩🇪 Suhl, Germany

Charité Berlin; 🇩🇪 Berlin, Germany