Lotta Alla Sepsi Ospedaliera - Fighting Hospital Sepsis
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| ClinicalTrials.gov Identifier: NCT01804764 |
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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
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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 |
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| Severe Sepsis |
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.
| 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 |
- An improvement in Sepsis Six Bundle implementation for Severe Sepsis and Septic Shock [ Time Frame: within 12 months after an Educational and Organizational Intervention ]
- All cause Mortality [ Time Frame: 1 month afte diagnosis of Severe Sepsis / Septic Shock ]
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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 |
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
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
| Contact: Gianpaola Monti, MD | 0039.0264.4472.09 | gianpaola.monti@ospedaleniguarda.it | |
| Contact: Angelo Calini, MD | 0039.0264.4472.09 | angelo.calini@ospedaleniguarda.it |
| Italy | |
| Niguarda Ca' Granda Hospital | Recruiting |
| Milan, Italy | |
| Contact: Gianpaola Monti, MD 0039.0264.4472.09 gianpaola.monti@ospedaleniguarda.it | |
| Sub-Investigator: Angelo Calini, MD | |
| Study Director: | Sergio Vesconi, MD | Niguarda Ca' Granda Hospital |
Publications:
| 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 |
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Severe Sepsis Septic Shock Sepsis Six bundle |
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Sepsis Toxemia Infections |
Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |