Medical Education for Sepsis Source Control and Antibiotics

NCT01187134 | Completed DMC

• 3 other identifiers: C1.101EO1002U1111-1118-2850
• Study Type: interventional
• Target: 4,138
• Locations: 1 country
• Sites: 42

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.

Conditions

Sepsis; Shock, Septic

Keywords

sepsis; shock, septic; quality assurance, health care; quality control; Survival Rate; Follow-Up Studies; Anti-Infective Agents/*therapeutic use

Outcome Measures

Primary Outcomes (1)

• All-cause mortality

  28 days

Secondary Outcomes (7)

• 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

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Behavioral: Change Management

Conventional CME

NO INTERVENTION

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.

Interventions

Change Management BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Center for Sepsis Control and Care, Germany: lead

Study Sites (42)

Universitätklinikum Aachen

Aachen, Germany

Location

Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH

Arnstadt, Germany

Location

HELIOS Klinikum Aue

Aue, Germany

Location

Zentralklinik Bad Berka GmbH

Bad Berka, Germany

Location

Hufelandkrankenhaus GmbH

Bad Langensalza, Germany

Location

Bundeswehrkrankenhaus Berlin

Berlin, Germany

Location

Charité Berlin

Berlin, Germany

Location

HELIOS Kliniken Berlin-Buch

Berlin, Germany

Location

HELIOS Klinikum Emil von Behring

Berlin, Germany

Location

Vivantes Klinikum Neukölln

Berlin, Germany

Location

Ev. Krankenhaus Bielefeld

Bielefeld, Germany

Location

HELIOS St. Josefs-Hospital Bochum-Linden

Bochum, Germany

Location

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

St. Georg Klinikum Eisenach gGmbH

Eisenach, Germany

Location

Waldkrankenhaus Rudolf Elle GmbH

Eisenberg, Germany

Location

Helios Klinikum Erfurt

Erfurt, Germany

Location

Katholisches Krankenhaus St. Johann Nepomuk

Erfurt, Germany

Location

Bürgerhospital Friedberg

Friedberg, Germany

Location

SRH Waldklinikum Gera

Gera, Germany

Location

Klinik am Eichert

Göppingen, Germany

Location

Ernst-Moritz-Arndt-Universität Greifswald

Greifswald, Germany

Location

Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH

Ilmenau, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Universitätsklinikum Kiel

Kiel, Germany

Location

HELIOS-Klinikum Krefeld GmbH

Krefeld, Germany

Location

Krankenhaus Landshut-Achdorf

Landshut, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

Klinikum Meiningen GmbH

Meiningen, Germany

Location

Saale-Unstrut-Klinikum Naumburg

Naumburg, Germany

Location

Südharz-Krankenhaus Nordhausen gGmbH

Nordhausen, Germany

Location

Klinikum Oldenburg

Oldenburg, Germany

Location

Thüringen-Klinik Pößneck gGmbH

Pößneck, Germany

Location

ASKLEPIOS-ASB Krankenhaus Radeberg GmbH

Radeberg, Germany

Location

Thüringen-Kliniken "Georgius Agricola" GmbH

Saalfeld, Germany

Location

Klinikum Saarbrücken gGmbH

Saarbrücken, Germany

Location

Diakonie-Klinikum Schwäbisch-Hall gGmbH

Schwäbisch Hall, Germany

Location

Ev. Jung-Stilling-Krankenhaus

Siegen, Germany

Location

SRH Zentralklinikum Suhl GmbH

Suhl, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

Sophien- und Hufeland-Klinikum gGmbH

Weimar, Germany

Location

HELIOS Klinikum Wuppertal

Wuppertal, Germany

Location

Related Publications (10)

• 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.

  PMID: 24589043 RESULT

• 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.

  PMID: 27546753 RESULT

• 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.

  PMID: 27776092 RESULT

• 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.

  PMID: 25891644 RESULT

• 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.

  PMID: 25466313 RESULT

• 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.

  PMID: 28466151 RESULT

• 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.

  PMID: 35273276 DERIVED

• 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.

  PMID: 35227308 DERIVED

• 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.

  PMID: 34674733 DERIVED

• 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.

  PMID: 29753321 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Change Management

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Organizational Innovation; Organization and Administration; Health Services Administration

Study Officials

• Reinhart Konrad, MD

  Jena University Hospital, Germany

  PRINCIPAL INVESTIGATOR

• Frank Bloos, MD, Ph.D.

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead investigator of the MEDUSA study group

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 23, 2010
• Study Start: July 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 9, 2017

Record last verified: 2017-08

Locations

DE (42)