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SepsisMEDUSANCT01187134

Medical Education for Sepsis Source Control and Antibiotics

A study testing Change Management in people with Sepsis and Shock, Septic, run by Center for Sepsis Control and Care, Germany at 42 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Sepsis, Shock, Septic
What is being tested?
Change Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,138 participants
Where
42 sitesGermany
Study dates
Jul 2011to Jul 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • Emergency department
  • Operating theatre
  • Regular ward
  • Intensive care unit (ICU)/Intermediate Care Unit (IMC)

Who cannot join

  • 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)

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

Germany42 sites

  • Universitätklinikum Aachen

    Aachen

  • Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH

    Arnstadt

  • HELIOS Klinikum Aue

    Aue

  • Zentralklinik Bad Berka GmbH

    Bad Berka

  • Hufelandkrankenhaus GmbH

    Bad Langensalza

  • Bundeswehrkrankenhaus Berlin

    Berlin

  • Charité Berlin

    Berlin

  • HELIOS Kliniken Berlin-Buch

    Berlin

  • HELIOS Klinikum Emil von Behring

    Berlin

  • Vivantes Klinikum Neukölln

    Berlin

  • Ev. Krankenhaus Bielefeld

    Bielefeld

  • HELIOS St. Josefs-Hospital Bochum-Linden

    Bochum

  • Universitätsklinikum Carl Gustav Carus

    Dresden

  • St. Georg Klinikum Eisenach gGmbH

    Eisenach

  • Waldkrankenhaus Rudolf Elle GmbH

    Eisenberg

  • Helios Klinikum Erfurt

    Erfurt

  • Katholisches Krankenhaus St. Johann Nepomuk

    Erfurt

  • Bürgerhospital Friedberg

    Friedberg

  • SRH Waldklinikum Gera

    Gera

  • Klinik am Eichert

    Göppingen

  • Ernst-Moritz-Arndt-Universität Greifswald

    Greifswald

  • Ilm-Kreis-Kliniken Arnstadt-Ilmenau GmbH

    Ilmenau

  • Universitätsklinikum Jena

    Jena

  • Universitätsklinikum Kiel

    Kiel

  • HELIOS-Klinikum Krefeld GmbH

    Krefeld

  • Krankenhaus Landshut-Achdorf

    Landshut

  • Universitätsklinikum Leipzig

    Leipzig

  • Klinikum Meiningen GmbH

    Meiningen

  • Saale-Unstrut-Klinikum Naumburg

    Naumburg

  • Südharz-Krankenhaus Nordhausen gGmbH

    Nordhausen

  • Klinikum Oldenburg

    Oldenburg

  • Thüringen-Klinik Pößneck gGmbH

    Pößneck

  • ASKLEPIOS-ASB Krankenhaus Radeberg GmbH

    Radeberg

  • Thüringen-Kliniken "Georgius Agricola" GmbH

    Saalfeld

  • Klinikum Saarbrücken gGmbH

    Saarbrücken

  • Diakonie-Klinikum Schwäbisch-Hall gGmbH

    Schwäbisch Hall

  • Ev. Jung-Stilling-Krankenhaus

    Siegen

  • SRH Zentralklinikum Suhl GmbH

    Suhl

  • Universitätsklinikum Tübingen

    Tübingen

  • Universitätsklinikum Ulm

    Ulm

  • Sophien- und Hufeland-Klinikum gGmbH

    Weimar

  • HELIOS Klinikum Wuppertal

    Wuppertal

Other trials in Germany

About this study

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.

Read the 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.

Being tested
Change Management
Keywords
sepsis, shock, septic, quality assurance, health care, quality control, Survival Rate, Follow-Up Studies, Anti-Infective Agents/*therapeutic use
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Change ManagementBehavioural

    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.

Study groups in NCT01187134
Study groupRoleWhat they receive
Intervention groupActive comparatorNot described
Receives: Behavioral: Change Management
Conventional CMENo interventionHospitals 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: 28 days

Secondary outcomes (7)

  1. Fraction of patients with antimicrobial therapy within 1 hour

  2. Duration until antimicrobial therapy

  3. Duration until focus control

  4. Frequency of blood cultures

  5. Frequency of adequate antimicrobial therapy

  6. ICU and hospital mortality

  7. ICU and and hospital length of stay

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2010 (estimated)
  2. Study startJul 2011
  3. Primary completionJun 2013
  4. Study completionJul 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01187134
Sponsor's protocol ID
C1.1
Other IDs
01EO1002, U1111-1118-2850
Acronym
MEDUSA
Status last verified
Aug 2017
First submitted
20 Aug 2010
Last updated
9 Aug 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24589043

  • 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.

    PubMed 27546753

  • 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.

    PubMed 27776092

  • 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.

    PubMed 25891644

  • 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.

    PubMed 25466313

  • 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.

    PubMed 28466151

  • 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.

    PubMed 35273276

  • 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.

    PubMed 35227308

  • 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.

    PubMed 34674733

  • 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.

    PubMed 29753321

Questions about this trial

What is this clinical trial studying?

A study testing Change Management in people with Sepsis and Shock, Septic, run by Center for Sepsis Control and Care, Germany at 42 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01187134, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.

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