Medical Education for Sepsis Source Control and Antibiotics
NCT ID: NCT01187134
Last Updated: 2017-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4138 participants
INTERVENTIONAL
2011-07-31
2013-07-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Intervention group
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
ALL
No
Sponsors
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Center for Sepsis Control and Care, Germany
OTHER
Responsible Party
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Frank Bloos
Lead investigator of the MEDUSA study group
Principal Investigators
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Reinhart Konrad, MD
Role: PRINCIPAL_INVESTIGATOR
Jena University Hospital, Germany
Frank Bloos, MD, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Jena University Hospital
Locations
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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, , Germany
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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01EO1002
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
U1111-1118-2850
Identifier Type: OTHER
Identifier Source: secondary_id
C1.1
Identifier Type: -
Identifier Source: org_study_id
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