Clinical trial NCT03299894: Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department
Official title: Usefulness of Routine qSOFA Calculation at Triage to Fasten Antimicrobial Administration in Patients With Bacterial Infection in the Emergency Department: a Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Infection
Intensive Care
Keywords: Sepsis
Shock, septic
Emergency service, hospital
Anti-infective agents
Outcome assessment
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 780
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients will be prospectively included at Emergency Department triage during 2 consecutive 6-month periods (1-month wash-out interlude between the 2 inclusion periods):

* First inclusion period: usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection.
* Second inclusion period: usual procedure for patient triage at Emergency Department admission PLUS routine calculation of qSOFA in all patients admitted to the Emergency Department with a suspected or proven bacterial infection. Patients with a qSOFA value ≥2 will be directly and immediately notified to Emergency Department physicians by triage nurses.
Primary purpose: DIAGNOSTIC

Brief summary: The delayed administration of an adequate antimicrobial therapy is a strong predictor of impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be initiated within one hour following the recognition of sepsis or septic shock.

The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which has been recently proposed by the Third International Sepsis Consensus Definitions Task Force (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min) and altered mentation (Glasgow coma scale \<15). The score ranges from 0 to 3 points. A qSOFA value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these outcomes being more common in infected patients who may be septic than in those with uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus improve the outcome of patients at risk of sepsis or septic shock.

Many patients admitted to the hospital for bacterial sepsis or septic shock are initially managed in the Emergency Department (ED). This study aims at investigating whether the routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial therapy in patients admitted to the ED with suspected or proven bacterial infection, especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3 definition).


Eligibility criteria: Inclusion Criteria:

• Suspected or proven bacterial infection at emergency department triage

Exclusion Criteria:

* Imminent death
* Pregnancy
* Breast-feeding
* For patients managed by a medicalized pre-hospital emergency team before ED admission : administration of a first dose of antimicrobial agent before ED admission
* Lack of coverage by the public health insurance system
* Patient's refusal for study enrollment
* Lack of confirmed bacterial infection (i.e., documented either clinically, microbiologically or by imaging procedures) in patients with a suspected bacterial infection at emergency departement triage

Primary outcomes:
measure: Proportion of patients who receive a first dose of antimicrobial agent
timeFrame: one hour
Secondary outcomes:
measure: Proportion of patients who receive a first dose of adequate antimicrobial agent
timeFrame: one hour
measure: Proportion of patients who receive a first dose of antimicrobial agent
timeFrame: three hours
measure: Proportion of patients who receive a first dose of adequate antimicrobial agent
timeFrame: three hours
measure: Proportion of patients with a decrease in SOFA score value ≥ 1 point
timeFrame: two days
measure: Proportion of patients requiring an admission to the Intensive Care Unit
timeFrame: two days
measure: In-hospital mortality at day 7
timeFrame: seven days
measure: Overall In-hospital mortality
timeFrame: through hospital discharge, up to 3 months
measure: Length of hospital stay
timeFrame: throught hospital discharge, up to 3 months
Other outcomes:
Locations:
city: Orléans
country: France
facility: Regional Hospital center of Orleans
Study officials:
affiliation: Regional Hospital Center of Orleans
name: Julien PASSERIEUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
citation: Petit J, Passerieux J, Maitre O, Guerin C, Rozelle C, Cordeau O, Cassonnet A, Malet A, Boulain T, Barbier F; qSOFAST study group. Impact of a qSOFA-based triage procedure on antibiotic timing in ED patients with sepsis: A prospective interventional study. Am J Emerg Med. 2020 Mar;38(3):477-484. doi: 10.1016/j.ajem.2019.05.022. Epub 2019 May 10.