Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department

Centre Hospitalier Régional d'Orléans780 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

780

Eligibility

Sex: ALLMin age: 18 YearsMax age: 105 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of patients who receive a first dose of antimicrobial agent

Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within one hour following triage in the emergency department.

Time frame: one hour

Secondary Outcomes

Proportion of patients who receive a first dose of adequate antimicrobial agent

Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and microbiologically documented infection who receive a first dose of adequate antimicrobial agent within one hour following triage in the emergency department.

Time frame: one hour

Proportion of patients who receive a first dose of antimicrobial agent

Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within 3 hours following triage in the emergency department.

Time frame: three hours

Proportion of patients who receive a first dose of adequate antimicrobial agent

Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and a microbiologically documented infection who receive a first dose of adequate antimicrobial agent within 3 hours following triage in the emergency department

Time frame: three hours

Proportion of patients with a decrease in SOFA score value ≥ 1 point

Proportion of patients with a decrease in SOFA score value ≥ 1 point between triage in the emergency department (Day 0) and Day 2 among those with an initial SOFA score value ≥ 1 point

Time frame: two days

Proportion of patients requiring an admission to the Intensive Care Unit

Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2

Time frame: two days

In-hospital mortality at day 7

Number of patients who died in hospital at day 7

Time frame: seven days

Overall In-hospital mortality

Number of patients who died in hospital during the hospital stay

Time frame: through hospital discharge, up to 3 months

Length of hospital stay

Number of days in hospital

Time frame: throught hospital discharge, up to 3 months

Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes