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Lotta Alla Sepsi Ospedaliera - Fighting Hospital Sepsis

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ClinicalTrials.gov Identifier: NCT01804764
Recruitment Status : Unknown
Verified February 2013 by University of Milano Bicocca.
Recruitment status was:  Recruiting
First Posted : March 5, 2013
Last Update Posted : March 5, 2013
Information provided by (Responsible Party):
University of Milano Bicocca

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.

Condition or disease
Severe Sepsis

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 Start Date : June 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

Primary Outcome Measures :
  1. An improvement in Sepsis Six Bundle implementation for Severe Sepsis and Septic Shock [ Time Frame: within 12 months after an Educational and Organizational Intervention ]

Secondary Outcome Measures :
  1. All cause Mortality [ Time Frame: 1 month afte diagnosis of Severe Sepsis / Septic Shock ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804764

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Contact: Gianpaola Monti, MD 0039.0264.4472.09 gianpaola.monti@ospedaleniguarda.it
Contact: Angelo Calini, MD 0039.0264.4472.09 angelo.calini@ospedaleniguarda.it

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Niguarda Ca' Granda Hospital Recruiting
Milan, Italy
Contact: Gianpaola Monti, MD    0039.0264.4472.09    gianpaola.monti@ospedaleniguarda.it   
Sub-Investigator: Angelo Calini, MD         
Sponsors and Collaborators
University of Milano Bicocca
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Study Director: Sergio Vesconi, MD Niguarda Ca' Granda Hospital
Additional Information:
Dellinger RP, Levy MM, Carlet JM, Bion J, Parker MM, Jaeschke R, Reinhart K, Angus DC, Brun-Buisson C, Beale R, Calandra T, Dhainaut JF, Gerlach H, Harvey M, Marini JJ, Marshall J, Ranieri M, Ramsay G, Sevransky J, Thompson BT, Townsend S, Vender JS, Zimmerman JL, Vincent JL; International Surviving Sepsis Campaign Guidelines Committee; American Association of Critical-Care Nurses; American College of Chest Physicians; American College of Emergency Physicians; Canadian Critical Care Society; European Society of Clinical Microbiology and Infectious Diseases; European Society of Intensive Care Medicine; European Respiratory Society; International Sepsis Forum; Japanese Association for Acute Medicine; Japanese Society of Intensive Care Medicine; Society of Critical Care Medicine; Society of Hospital Medicine; Surgical Infection Society; World Federation of Societies of Intensive and Critical Care Medicine. Surviving Sepsis Campaign: international guidelines for management of severe sepsis and septic shock: 2008. Crit Care Med. 2008 Jan;36(1):296-327. doi: 10.1097/01.CCM.0000298158.12101.41. Erratum In: Crit Care Med. 2008 Apr;36(4):1394-6.

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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT01804764    
Other Study ID Numbers: IX/001137-23/12/2010
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: March 5, 2013
Last Verified: February 2013
Keywords provided by University of Milano Bicocca:
Severe Sepsis
Septic Shock
Sepsis Six bundle
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes