Implementation of a qSOFA Score in the Emergency Department

Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04568746
• Other study ID #: P/2019/452
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: September 2020
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Mathilde BOISTON
• Phone: 033381668951
• Email: mboiston[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: November 1, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis

Intervention

Procedure:
• emergency vital room
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
• box
patient with score < 2 will be supported in box

Locations

Country	Name	City	State
France	Chu Besancon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rate	compare mortality rate with orientation in emergency	28 days
Secondary	support time to medical contact	compare support time with orientation of patients according to the orientation of the patient in the emergency department	1 day
Secondary	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	1 day