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Implementation of a qSOFA Score in the Emergency Department (qSOFA2)

Primary Purpose

Sepsis

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

emergency vital room

box

About this trial

This is an interventional screening trial for Sepsis focused on measuring screening, qSOFA, sepsis, Emergency care unit

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

body temperature below 36 °C or above 38 °C
require hospitalization

Exclusion Criteria:

hospital transfer,
patients with pre hospital care
language barrier,
refusal to participate

Sites / Locations

Chu BesanconRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

patients with qSOFA ≥ 2

patients with qSOFA <2

Arm Description

adult patients with a qSOFA score ≥ 2 at the screening in the emergency department, will be referred to the emergency vital room

adult patients with a qSOFA score < 2 at the screening in the emergency department, will be referred to the box

Outcomes

Primary Outcome Measures

mortality rate

compare mortality rate with orientation in emergency

Secondary Outcome Measures

support time to medical contact

compare support time with orientation of patients according to the orientation of the patient in the emergency department

support time to initiation of antibiotics

compare support time with initiation antibiotics of patients according to the orientation of the patient in the emergency department

Full Information

NCT ID

NCT04568746

First Posted

September 24, 2020

Last Updated

October 15, 2020

Sponsor

Centre Hospitalier Universitaire de Besancon

1. Study Identification

Unique Protocol Identification Number

NCT04568746

Brief Title

Implementation of a qSOFA Score in the Emergency Department

Acronym

qSOFA2

Official Title

Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 12, 2020 (Actual)

Primary Completion Date

September 30, 2021 (Anticipated)

Study Completion Date

November 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Universitaire de Besancon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score <2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sepsis

Keywords

screening, qSOFA, sepsis, Emergency care unit

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patients with qSOFA ≥ 2

Arm Type

Other

Arm Description

adult patients with a qSOFA score ≥ 2 at the screening in the emergency department, will be referred to the emergency vital room

Arm Title

patients with qSOFA <2

Arm Type

Other

Arm Description

adult patients with a qSOFA score < 2 at the screening in the emergency department, will be referred to the box

Intervention Type

Procedure

Intervention Name(s)

emergency vital room

Intervention Description

At the arrival of the patient, the qSOFA will be carried out to guide the orientation. Patient with score ≥ 2 will be supported in emergency vital room

Intervention Type

Procedure

Intervention Name(s)

box

Intervention Description

patient with score < 2 will be supported in box

Primary Outcome Measure Information:

Title

mortality rate

Description

compare mortality rate with orientation in emergency

Time Frame

28 days

Secondary Outcome Measure Information:

Title

support time to medical contact

Description

compare support time with orientation of patients according to the orientation of the patient in the emergency department

Time Frame

1 day

Title

support time to initiation of antibiotics

Description

compare support time with initiation antibiotics of patients according to the orientation of the patient in the emergency department

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: body temperature below 36 °C or above 38 °C require hospitalization Exclusion Criteria: hospital transfer, patients with pre hospital care language barrier, refusal to participate

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mathilde BOISTON

Phone

033381668951

mboiston@chu-besancon.fr

Facility Information:

Facility Name

Chu Besancon

City

Besançon

ZIP/Postal Code

25000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathilde BOISTON

mboiston@chu-besancon.fr

First Name & Middle Initial & Last Name & Degree

Tania MARX

Phone

033381668162

tmarx@chu-besancon.fr

12. IPD Sharing Statement

Learn more about this trial

Implementation of a qSOFA Score in the Emergency Department

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