Implementation of a qSOFA Score in the Emergency Department

NCT04568746 | Completed

• 1 other identifier: P/2019/452
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Keywords

screening; qSOFA; sepsis; Emergency care unit

Outcome Measures

Primary Outcomes (1)

• mortality rate

  compare mortality rate with orientation in emergency

  28 days

Secondary Outcomes (2)

• support time to medical contact

  1 day

• support time to initiation of antibiotics

  1 day

Study Arms (2)

patients with qSOFA ≥ 2

OTHER

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

Procedure: emergency vital room

patients with qSOFA <2

OTHER

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

Procedure: box

Interventions

emergency vital room 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

box PROCEDURE

patient with score \< 2 will be supported in box

patients with qSOFA <2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead

Study Sites (1)

Chu Besancon

Besançon, 25000, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: September 29, 2020
• Study Start: October 12, 2020
• Primary Completion: October 12, 2021
• Study Completion: November 12, 2021
• Last Updated: January 16, 2025

Record last verified: 2025-01

Locations

FR (1)