Implementation of a qSOFA Score in the Emergency Department

NCT ID: NCT04568746

Last Updated: 2025-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2021-11-12

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.

Conditions

Sepsis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

patients with qSOFA ≥ 2

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

Group Type: OTHER

emergency vital room

Intervention Type: PROCEDURE

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

patients with qSOFA <2

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

Group Type: OTHER

box

Intervention Type: PROCEDURE

patient with score \< 2 will be supported in box

Interventions

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

Intervention Type: PROCEDURE

box

patient with score \< 2 will be supported in box

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Besancon

Besançon, , France

Countries

France

Other Identifiers

P/2019/452

Identifier Type: -

Identifier Source: org_study_id