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

Centre Hospitalier Régional d'Orléans

Status: Completed

Conditions: Bacterial Infection; Intensive Care

Treatments: Procedure: systematic calculation of qSOFA

Study type: Interventional

Funder types: Other

Identifiers

NCT03299894

CHRO 2017-06

Details and patient eligibility

About

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).

Enrollment: 780 patients

Sex: All

Ages: 18 to 105 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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780 participants in 2 patient groups

systematic calculation of qSOFA

Experimental group

Description:

Usual procedure for patient triage AND systematic calculation of qSOFA at Emergency Department triage in patients admitted with a suspected or proven bacterial infection.

Treatment:

Procedure: systematic calculation of qSOFA

no systematic calculation of qSOFA

No Intervention group

Description:

Usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection. No systematic calculation of qSOFA.