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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 228

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Retrospective study in patients admitted to the emergency department in the CHR Metz-Thionville

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between lactate levels and mortality	lactate levels at their admission	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: November 20, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 23, 2023
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: 2016-05Obs-CHRMT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No