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NCT03355833 Clinical Trial

Comparing Prognostic Performance of SEPSIS 2 and SEPSIS 3 Strategies at the Emergency Service

Sepsis Clinical Trial

— StraSEP  

Official title:
Comparing Prognostic Performance of SEPSIS 2 and SEPSIS 3 Strategies at the Emergency Service

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03355833
Other study ID # 2016-05Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date December 2016

Study information
Verified date November 2017
Source Centre Hospitalier Régional Metz-Thionville
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In 2016, the Third International Consensus proposed a new strategy to screen aggravating risk in patients with septic shock. This strategy is based on quick-SOFA and the SOFA score. The main objective is to compare the prognostic performance of SEPSIS 3 against the previous strategy SEPSIS 2 to predict the admission in intensive care unit or the intra-hospital death.

Description:

This study compare the prognostic performance of two strategies. It's a monocentric, retrospective study in patients admitted to the emergency department.

Recruitment information / eligibility
Status Completed
Enrollment 228
Est. completion date December 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Aged of 18 years or more - Initiation of one or more antibiotics in the Accident and Emergency Department in the Metz-Thionville hospital (CHR) site Mercy, for curative purpose, regardless of the infectious aetiology - Hospitalized in the CHR Metz-Thionville thereafter Exclusion Criteria: - Minors patients - Absence of antibiotic treatment initiated in the Emergency department - Prescription of antibiotic treatment in the emergency department for preventive purpose - Transferred by hospitalisation service of CHR Metz-Thionville in the emergency department - Absence of hospitalisation following their passage through the emergency department - Transferred to hospitalisation in an other establishment - Presence, at the admission, of an antibiotic treatment - Patients deceased in the emergency department

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville

Outcome
Type Measure Description Time frame Safety issue
Primary Intrinsic and Extrinsic properties of SEPSIS 3 strategy The percentage of patients with high qSOFA score (2 or more) who were admitted in intensive care unit or who have died during their stay in hospital and rather the percentage of patients with a small qSOFA score who survived without passing through intensive care unit Day 1
Secondary Correlation between lactate levels and mortality lactate levels at their admission Day 1
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