Clinical trial NCT01187134: Medical Education for Sepsis Source Control and Antibiotics
Official title: Medical Education for Sepsis Source Control and Antibiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Shock, Septic
Keywords: sepsis
shock, septic
quality assurance, health care
quality control
Survival Rate
Follow-Up Studies
Anti-Infective Agents/*therapeutic use
Lead sponsor: Center for Sepsis Control and Care, Germany
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 4138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: All-cause mortality
timeFrame: 28 days
Secondary outcomes:
measure: Fraction of patients with antimicrobial therapy within 1 hour
measure: Duration until antimicrobial therapy
measure: Duration until focus control
measure: Frequency of blood cultures
measure: Frequency of adequate antimicrobial therapy
measure: ICU and hospital mortality
measure: ICU and and hospital length of stay
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Universitätklinikum Aachen
city: Arnstadt
country: Germany
facility: Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
city: Aue
country: Germany
facility: HELIOS Klinikum Aue
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka GmbH
city: Bad Langensalza
country: Germany
facility: Hufelandkrankenhaus GmbH
city: Berlin
country: Germany
facility: Bundeswehrkrankenhaus Berlin
city: Berlin
country: Germany
facility: Charité Berlin
city: Berlin
country: Germany
facility: HELIOS Kliniken Berlin-Buch
city: Berlin
country: Germany
facility: HELIOS Klinikum Emil von Behring
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Bielefeld
country: Germany
facility: Ev. Krankenhaus Bielefeld
city: Bochum
country: Germany
facility: HELIOS St. Josefs-Hospital Bochum-Linden
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
city: Eisenach
country: Germany
facility: St. Georg Klinikum Eisenach gGmbH
city: Eisenberg
country: Germany
facility: Waldkrankenhaus Rudolf Elle GmbH
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
city: Erfurt
country: Germany
facility: Katholisches Krankenhaus St. Johann Nepomuk
city: Friedberg
country: Germany
facility: Bürgerhospital Friedberg
city: Gera
country: Germany
facility: SRH Waldklinikum Gera
city: Greifswald
country: Germany
facility: Ernst-Moritz-Arndt-Universität Greifswald
city: Göppingen
country: Germany
facility: Klinik am Eichert
city: Ilmenau
country: Germany
facility: Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH
city: Jena
country: Germany
facility: Universitätsklinikum Jena
city: Kiel
country: Germany
facility: Universitätsklinikum Kiel
city: Krefeld
country: Germany
facility: HELIOS-Klinikum Krefeld GmbH
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Meiningen
country: Germany
facility: Klinikum Meiningen GmbH
city: Naumburg
country: Germany
facility: Saale-Unstrut-Klinikum Naumburg
city: Nordhausen
country: Germany
facility: Südharz-Krankenhaus Nordhausen gGmbH
city: Oldenburg
country: Germany
facility: Klinikum Oldenburg
city: Pößneck
country: Germany
facility: Thüringen-Klinik Pößneck gGmbH
city: Radeberg
country: Germany
facility: ASKLEPIOS-ASB Krankenhaus Radeberg GmbH
city: Saalfeld
country: Germany
facility: Thüringen-Kliniken "Georgius Agricola" GmbH
city: Saarbrücken
country: Germany
facility: Klinikum Saarbrücken gGmbH
city: Schwäbisch-Hall
country: Germany
facility: Diakonie-Klinikum Schwäbisch-Hall gGmbH
city: Siegen
country: Germany
facility: Ev. Jung-Stilling-Krankenhaus
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl GmbH
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Weimar
country: Germany
facility: Sophien- und Hufeland-Klinikum gGmbH
city: Wuppertal
country: Germany
facility: HELIOS Klinikum Wuppertal
Study officials:
affiliation: Jena University Hospital, Germany
name: Reinhart Konrad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jena University Hospital
name: Frank Bloos, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.