Medical Education for Sepsis Source Control and Antibiotics

Sepsis Clinical Trial

— MEDUSA  

Official title:

Medical Education for Sepsis Source Control and Antibiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01187134
• Other study ID #: C1.1
• Secondary ID: 01EO1002U1111-11
• Status: Completed
• Phase: N/A
• First received: August 20, 2010
• Last updated: August 8, 2017
• Start date: July 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2017
• Source: Center for Sepsis Control and Care, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4138
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Sepsis
• Shock, Septic
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
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	Bundeswehrkrankenhaus Berlin	Berlin
Germany	Charité Berlin	Berlin
Germany	HELIOS Kliniken Berlin-Buch	Berlin
Germany	HELIOS Klinikum Emil von Behring	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	Helios Klinikum Erfurt	Erfurt
Germany	Katholisches Krankenhaus St. Johann Nepomuk	Erfurt
Germany	Bürgerhospital Friedberg	Friedberg
Germany	SRH Waldklinikum Gera	Gera
Germany	Klinik am Eichert	Göppingen
Germany	Ernst-Moritz-Arndt-Universität Greifswald	Greifswald
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

Sponsors (1)

Lead Sponsor	Collaborator
Center for Sepsis Control and Care, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Bloos F, Rüddel H, Thomas-Rüddel D, Schwarzkopf D, Pausch C, Harbarth S, Schreiber T, Gründling M, Marshall J, Simon P, Levy MM, Weiss M, Weyland A, Gerlach H, Schürholz T, Engel C, Matthäus-Krämer C, Scheer C, Bach F, Riessen R, Poidinger B, Dey K, Weile — View Citation

Bloos F, Thomas-Rüddel D, Rüddel H, Engel C, Schwarzkopf D, Marshall JC, Harbarth S, Simon P, Riessen R, Keh D, Dey K, Weiß M, Toussaint S, Schädler D, Weyland A, Ragaller M, Schwarzkopf K, Eiche J, Kuhnle G, Hoyer H, Hartog C, Kaisers U, Reinhart K; MEDU — View Citation

Matthaeus-Kraemer CT, Thomas-Rueddel DO, Schwarzkopf D, Rueddel H, Poidinger B, Reinhart K, Bloos F. Barriers and supportive conditions to improve quality of care for critically ill patients: A team approach to quality improvement. J Crit Care. 2015 Aug;3 — View Citation

Matthaeus-Kraemer CT, Thomas-Rueddel DO, Schwarzkopf D, Rueddel H, Poidinger B, Reinhart K, Bloos F. Crossing the handover chasm: Clinicians' perceptions of barriers to the early detection and timely management of severe sepsis and septic shock. J Crit Ca — View Citation

Schwarzkopf D, Rüddel H, Thomas-Rüddel DO, Felfe J, Poidinger B, Matthäus-Krämer CT, Hartog CS, Bloos F. Perceived Nonbeneficial Treatment of Patients, Burnout, and Intention to Leave the Job Among ICU Nurses and Junior and Senior Physicians. Crit Care Me — View Citation

Thomas-Rueddel DO, Poidinger B, Weiss M, Bach F, Dey K, Häberle H, Kaisers U, Rüddel H, Schädler D, Scheer C, Schreiber T, Schürholz T, Simon P, Sommerer A, Schwarzkopf D, Weyland A, Wöbker G, Reinhart K, Bloos F; Medical Education for Sepsis Source Contr — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality		28 days
Secondary	Fraction of patients with antimicrobial therapy within 1 hour
Secondary	Duration until antimicrobial therapy
Secondary	Duration until focus control
Secondary	Frequency of blood cultures
Secondary	Frequency of adequate antimicrobial therapy
Secondary	ICU and hospital mortality
Secondary	ICU and and hospital length of stay

External Links

•   Center for Sepsis Control & Care
•   MEDUSA-Study