Skip to main content
OpenTrials
Completed

NCT Number: NCT01804764

Lotta Alla Sepsi Ospedaliera - Fighting Hospital Sepsis

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Niguarda Ca' Granda Hospital

Milan, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. All cause Mortality

    Time frame: 1 month afte diagnosis of Severe Sepsis / Septic Shock

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

Educational and Organizational Intervention's Effect on Severe Sepsis and Septic Shock Management Out of Intensive Care Units: Medical Wards and Emergency Departments

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2013
Registry last updated
May 9, 2023

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.

Published trials that share one or more normalized conditions with this study.