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Completed

NCT Number: NCT01187134

Medical Education for Sepsis Source Control and Antibiotics

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätklinikum Aachen, Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. All-cause mortality

    Time frame: 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Center for Sepsis Control and Care, Germany

Other

Registry information

Acronym: MEDUSA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 23, 2010
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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