Clinical trial NCT01804764: Lotta Alla Sepsi Ospedaliera - Fighting Hospital Sepsis
Official title: Educational and Organizational Intervention's Effect on Severe Sepsis and Septic Shock Management Out of Intensive Care Units: Medical Wards and Emergency Departments
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Severe Sepsis
Keywords: Severe Sepsis
Septic Shock
Sepsis Six bundle
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2013-03-05
Enrollment: 1123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the Emergency Department out-patients and the Medical Wards in -patients presenting with suspected svere sepsis or septic shock

Brief summary: Sepsis is widespread (1.8 million cases annually worldwide) and accounts for a very high mortality: 20-25% of all severe sepsis, 40-70% of all septic shock. The Surviving Sepsis Campaign (SSC) recommends a first 6 hours "resuscitative bundle" to improve patient's outcome. Despite this, the bundle is poorly performed, because of a superficial knowledge of the guidelines and several difficulties in their clinical implementation. In recognition of this, a "sepsis six" bundle is designed to facilitate early intervention with just three diagnostic and three therapeutic steps to be delivered by staff within 1 h.

The aim of our study is to evaluate if an Educational and Organizational Intervention (EOI) could improve septic patient's outcome in no Critical Care Units. The second endpoint is to evaluate if the compliance to the "sepsis six" bundle could improve after this sort of intervention.

Detailed description: Methods 39 Medical Wards and 12 Emergency Departments, belonging to 12 hospitals, were voluntarily enrolled. Through the collaboration of 12 Multidisciplinary Teams (MT), we took a Pre-EOI picture of the human resources (i.e. doctors to patients ratio) and of the organisational structures (i.e. laboratory's opening hours) of each hospital. For six months, each unit enrolled was asked to fill in a Clinical Checklist for every patient suspected for severe sepsis or septic shock; so that the Pre-EOI "sepsis six" bundle compliance could be evaluated. Then, we planned several pre-agreed educational meetings for all of the doctors and nurses belonging to the enrolled wards. In the meanwhile the MT worked to overcome any impediment to a better septic patient management. Finally, the educated medical staff was asked to fill in again the same Clinical Checklist used in the Pre-EOI phase; so that the Post-EOI "sepsis six" bundle compliance could be evaluated and a comparison with the Pre-EOI phase could be done.

Hypothesis This is the first study aimed to analyze the impact of an Educational and Organizational Intervention in the outcome of septic patients managed in no Critical Care Units. We guess that the differences showed in human resources and organizational structures among the hospitals could have a role in the "sepsis six" bundle compliance and in the patient's outcome, but only a comparison with data collected from the clinical checklist and patient's outcome will confirm our guess. Likewise, we believe that an educational intervention could improve the septic patient's management, but we need the Post-EOI phase conclusion to demonstrate or not our hypothesis.

Eligibility criteria: Inclusion Criteria:

* Any patient having a SIRS due to Sepsis and at least on of the following criteria: Systolic Blood Pressure \< 90 mmHg and/or serum lactate \> 4 mg/dl and/or organ failure

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: An improvement in Sepsis Six Bundle implementation for Severe Sepsis and Septic Shock
timeFrame: within 12 months after an Educational and Organizational Intervention
Secondary outcomes:
measure: All cause Mortality
timeFrame: 1 month afte diagnosis of Severe Sepsis / Septic Shock
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Niguarda Ca' Granda Hospital
Study officials:
affiliation: Niguarda Ca' Granda Hospital
name: Sergio Vesconi, MD
role: STUDY_DIRECTOR
References:
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