NCT03355833

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
Last Updated

August 24, 2023

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

November 20, 2017

Last Update Submit

August 23, 2023

Conditions

Sepsis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Correlation between lactate levels and mortality

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 28, 2017

Study Start

January 1, 2016

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

August 24, 2023

Record last verified: 2017-11