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Severe Sepsis | Lotta Alla Sepsi Ospedaliera - Fighting Hospital Sepsis

Severe Sepsis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Severe Sepsis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Unknown status

Start Date: June 2011

Completed Date: March 2013

Phase:

Type: Observational

Design:

Primary Outcome: An improvement in Sepsis Six Bundle implementation for Severe Sepsis and Septic Shock

Secondary Outcome: All cause Mortality

Study sponsors, principal investigator, and references

Principal Investigator: Sergio Vesconi, MD

Lead Sponsor: University of Milano Bicocca

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01804764

Cardoso T, Carneiro AH, Ribeiro O, Teixeira-Pinto A, Costa-Pereira A. Reducing mortality in severe sepsis with the implementation of a core 6-hour bundle: results from the Portuguese community-acquired sepsis study (SACiUCI study). Crit Care. 2010;14(3):R83. doi: 10.1186/cc9008. Epub 2010 May 10.

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