search
Back to results

Medical Education for Sepsis Source Control and Antibiotics (MEDUSA)

Primary Purpose

Sepsis, Shock, Septic

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Change Management
Sponsored by
Center for Sepsis Control and Care, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Sepsis focused on measuring sepsis, shock, septic, quality assurance, health care, quality control, Survival Rate, Follow-Up Studies, Anti-Infective Agents/*therapeutic use

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Universitätklinikum Aachen
  • Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
  • HELIOS Klinikum Aue
  • Zentralklinik Bad Berka GmbH
  • Hufelandkrankenhaus GmbH
  • Bundeswehrkrankenhaus Berlin
  • Charité Berlin
  • HELIOS Kliniken Berlin-Buch
  • HELIOS Klinikum Emil von Behring
  • Vivantes Klinikum Neukölln
  • Ev. Krankenhaus Bielefeld
  • HELIOS St. Josefs-Hospital Bochum-Linden
  • Universitätsklinikum Carl Gustav Carus
  • St. Georg Klinikum Eisenach gGmbH
  • Waldkrankenhaus Rudolf Elle GmbH
  • Helios Klinikum Erfurt
  • Katholisches Krankenhaus St. Johann Nepomuk
  • Bürgerhospital Friedberg
  • SRH Waldklinikum Gera
  • Ernst-Moritz-Arndt-Universität Greifswald
  • Klinik am Eichert
  • Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
  • Universitätsklinikum Jena
  • Universitätsklinikum Kiel
  • HELIOS-Klinikum Krefeld GmbH
  • Krankenhaus Landshut-Achdorf
  • Universitätsklinikum Leipzig
  • Klinikum Meiningen GmbH
  • Saale-Unstrut-Klinikum Naumburg
  • Südharz-Krankenhaus Nordhausen gGmbH
  • Klinikum Oldenburg
  • Thüringen-Klinik Pößneck gGmbH
  • ASKLEPIOS-ASB Krankenhaus Radeberg GmbH
  • Thüringen-Kliniken "Georgius Agricola" GmbH
  • Klinikum Saarbrücken gGmbH
  • Diakonie-Klinikum Schwäbisch-Hall gGmbH
  • Ev. Jung-Stilling-Krankenhaus
  • SRH Zentralklinikum Suhl GmbH
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Ulm
  • Sophien- und Hufeland-Klinikum gGmbH
  • HELIOS Klinikum Wuppertal

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention group

Conventional CME

Arm Description

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.

Outcomes

Primary Outcome Measures

All-cause mortality

Secondary Outcome Measures

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

Full Information

First Posted
August 20, 2010
Last Updated
August 8, 2017
Sponsor
Center for Sepsis Control and Care, Germany
search

1. Study Identification

Unique Protocol Identification Number
NCT01187134
Brief Title
Medical Education for Sepsis Source Control and Antibiotics
Acronym
MEDUSA
Official Title
Medical Education for Sepsis Source Control and Antibiotics
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Sepsis Control and Care, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Shock, Septic
Keywords
sepsis, shock, septic, quality assurance, health care, quality control, Survival Rate, Follow-Up Studies, Anti-Infective Agents/*therapeutic use

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Title
Conventional CME
Arm Type
No Intervention
Arm Description
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 Type
Behavioral
Intervention Name(s)
Change Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Fraction of patients with antimicrobial therapy within 1 hour
Title
Duration until antimicrobial therapy
Title
Duration until focus control
Title
Frequency of blood cultures
Title
Frequency of adequate antimicrobial therapy
Title
ICU and hospital mortality
Title
ICU and and hospital length of stay

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For the hospitals (cluster): Involved in the primary care of patients with severe sepsis/septic shock Willing to participate in a guideline implementation process For the patients: New onset of suspicion of severe sepsis or septic shock in the following settings: Prehospital Emergency department Operating theatre Regular ward Intensive care unit (ICU)/Intermediate Care Unit (IMC) Exclusion Criteria: For the hospitals (cluster): No intensive care unit available no acute care for patients with severe sepsis and septic shock 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhart Konrad, MD
Organizational Affiliation
Jena University Hospital, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frank Bloos, MD, Ph.D.
Organizational Affiliation
Jena University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätklinikum Aachen
City
Aachen
Country
Germany
Facility Name
Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
City
Arnstadt
Country
Germany
Facility Name
HELIOS Klinikum Aue
City
Aue
Country
Germany
Facility Name
Zentralklinik Bad Berka GmbH
City
Bad Berka
Country
Germany
Facility Name
Hufelandkrankenhaus GmbH
City
Bad Langensalza
Country
Germany
Facility Name
Bundeswehrkrankenhaus Berlin
City
Berlin
Country
Germany
Facility Name
Charité Berlin
City
Berlin
Country
Germany
Facility Name
HELIOS Kliniken Berlin-Buch
City
Berlin
Country
Germany
Facility Name
HELIOS Klinikum Emil von Behring
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum Neukölln
City
Berlin
Country
Germany
Facility Name
Ev. Krankenhaus Bielefeld
City
Bielefeld
Country
Germany
Facility Name
HELIOS St. Josefs-Hospital Bochum-Linden
City
Bochum
Country
Germany
Facility Name
Universitätsklinikum Carl Gustav Carus
City
Dresden
Country
Germany
Facility Name
St. Georg Klinikum Eisenach gGmbH
City
Eisenach
Country
Germany
Facility Name
Waldkrankenhaus Rudolf Elle GmbH
City
Eisenberg
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
Country
Germany
Facility Name
Katholisches Krankenhaus St. Johann Nepomuk
City
Erfurt
Country
Germany
Facility Name
Bürgerhospital Friedberg
City
Friedberg
Country
Germany
Facility Name
SRH Waldklinikum Gera
City
Gera
Country
Germany
Facility Name
Ernst-Moritz-Arndt-Universität Greifswald
City
Greifswald
Country
Germany
Facility Name
Klinik am Eichert
City
Göppingen
Country
Germany
Facility Name
Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
City
Ilmenau
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
Country
Germany
Facility Name
Universitätsklinikum Kiel
City
Kiel
Country
Germany
Facility Name
HELIOS-Klinikum Krefeld GmbH
City
Krefeld
Country
Germany
Facility Name
Krankenhaus Landshut-Achdorf
City
Landshut
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
Country
Germany
Facility Name
Klinikum Meiningen GmbH
City
Meiningen
Country
Germany
Facility Name
Saale-Unstrut-Klinikum Naumburg
City
Naumburg
Country
Germany
Facility Name
Südharz-Krankenhaus Nordhausen gGmbH
City
Nordhausen
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
Country
Germany
Facility Name
Thüringen-Klinik Pößneck gGmbH
City
Pößneck
Country
Germany
Facility Name
ASKLEPIOS-ASB Krankenhaus Radeberg GmbH
City
Radeberg
Country
Germany
Facility Name
Thüringen-Kliniken "Georgius Agricola" GmbH
City
Saalfeld
Country
Germany
Facility Name
Klinikum Saarbrücken gGmbH
City
Saarbrücken
Country
Germany
Facility Name
Diakonie-Klinikum Schwäbisch-Hall gGmbH
City
Schwäbisch-Hall
Country
Germany
Facility Name
Ev. Jung-Stilling-Krankenhaus
City
Siegen
Country
Germany
Facility Name
SRH Zentralklinikum Suhl GmbH
City
Suhl
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
Country
Germany
Facility Name
Sophien- und Hufeland-Klinikum gGmbH
City
Weimar
Country
Germany
Facility Name
HELIOS Klinikum Wuppertal
City
Wuppertal
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24589043
Citation
Bloos F, Thomas-Ruddel D, Ruddel H, Engel C, Schwarzkopf D, Marshall JC, Harbarth S, Simon P, Riessen R, Keh D, Dey K, Weiss M, Toussaint S, Schadler D, Weyland A, Ragaller M, Schwarzkopf K, Eiche J, Kuhnle G, Hoyer H, Hartog C, Kaisers U, Reinhart K; MEDUSA Study Group. Impact of compliance with infection management guidelines on outcome in patients with severe sepsis: a prospective observational multi-center study. Crit Care. 2014 Mar 3;18(2):R42. doi: 10.1186/cc13755.
Results Reference
result
PubMed Identifier
27546753
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 Care. 2016 Dec;36:85-91. doi: 10.1016/j.jcrc.2016.06.034. Epub 2016 Jul 9.
Results Reference
result
PubMed Identifier
27776092
Citation
Schwarzkopf D, Ruddel H, Thomas-Ruddel DO, Felfe J, Poidinger B, Matthaus-Kramer 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 Med. 2017 Mar;45(3):e265-e273. doi: 10.1097/CCM.0000000000002081.
Results Reference
result
PubMed Identifier
25891644
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;30(4):685-91. doi: 10.1016/j.jcrc.2015.03.022. Epub 2015 Apr 1.
Results Reference
result
PubMed Identifier
25466313
Citation
Thomas-Rueddel DO, Poidinger B, Weiss M, Bach F, Dey K, Haberle H, Kaisers U, Ruddel H, Schadler D, Scheer C, Schreiber T, Schurholz T, Simon P, Sommerer A, Schwarzkopf D, Weyland A, Wobker G, Reinhart K, Bloos F; Medical Education for Sepsis Source Control and Antibiotics Study Group. Hyperlactatemia is an independent predictor of mortality and denotes distinct subtypes of severe sepsis and septic shock. J Crit Care. 2015 Apr;30(2):439.e1-6. doi: 10.1016/j.jcrc.2014.10.027. Epub 2014 Oct 30.
Results Reference
result
PubMed Identifier
28466151
Citation
Bloos F, Ruddel H, Thomas-Ruddel D, Schwarzkopf D, Pausch C, Harbarth S, Schreiber T, Grundling M, Marshall J, Simon P, Levy MM, Weiss M, Weyland A, Gerlach H, Schurholz T, Engel C, Matthaus-Kramer C, Scheer C, Bach F, Riessen R, Poidinger B, Dey K, Weiler N, Meier-Hellmann A, Haberle HH, Wobker G, Kaisers UX, Reinhart K; MEDUSA study group. Effect of a multifaceted educational intervention for anti-infectious measures on sepsis mortality: a cluster randomized trial. Intensive Care Med. 2017 Nov;43(11):1602-1612. doi: 10.1007/s00134-017-4782-4. Epub 2017 May 2.
Results Reference
result
PubMed Identifier
35273276
Citation
Schwarzkopf D, Matthaeus-Kraemer CT, Thomas-Ruddel DO, Ruddel H, Poidinger B, Bach F, Gerlach H, Grundling M, Lindner M, Scheer C, Simon P, Weiss M, Reinhart K, Bloos F; MEDUSA study group. A multifaceted educational intervention improved anti-infectious measures but had no effect on mortality in patients with severe sepsis. Sci Rep. 2022 Mar 10;12(1):3925. doi: 10.1038/s41598-022-07915-9.
Results Reference
derived
PubMed Identifier
35227308
Citation
Ruddel H, Thomas-Ruddel DO, Reinhart K, Bach F, Gerlach H, Lindner M, Marshall JC, Simon P, Weiss M, Bloos F, Schwarzkopf D; MEDUSA study group. Adverse effects of delayed antimicrobial treatment and surgical source control in adults with sepsis: results of a planned secondary analysis of a cluster-randomized controlled trial. Crit Care. 2022 Feb 28;26(1):51. doi: 10.1186/s13054-022-03901-9.
Results Reference
derived
PubMed Identifier
34674733
Citation
Thomas-Ruddel DO, Hoffmann P, Schwarzkopf D, Scheer C, Bach F, Komann M, Gerlach H, Weiss M, Lindner M, Ruddel H, Simon P, Kuhn SO, Wetzker R, Bauer M, Reinhart K, Bloos F; MEDUSA study group. Fever and hypothermia represent two populations of sepsis patients and are associated with outside temperature. Crit Care. 2021 Oct 21;25(1):368. doi: 10.1186/s13054-021-03776-2.
Results Reference
derived
PubMed Identifier
29753321
Citation
Thomas-Ruddel DO, Poidinger B, Kott M, Weiss M, Reinhart K, Bloos F; MEDUSA study group. Influence of pathogen and focus of infection on procalcitonin values in sepsis patients with bacteremia or candidemia. Crit Care. 2018 May 13;22(1):128. doi: 10.1186/s13054-018-2050-9.
Results Reference
derived
Links:
URL
http://www.cscc.uniklinikum-jena.de/cscc/en/CSCC.html
Description
Center for Sepsis Control & Care

Learn more about this trial

Medical Education for Sepsis Source Control and Antibiotics

We'll reach out to this number within 24 hrs