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

Not Applicable

Completed

• Conditions: Bacterial Infection; Intensive Care
• Interventions: Procedure: systematic calculation of qSOFA

• Registration Number: NCT03299894
• Lead Sponsor: Centre Hospitalier Régional d'Orléans

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-03
• Study Start: 2017-10-12
• Primary Completion: 2018-06-10
• Study Completion: 2018-06-10
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 780

Inclusion Criteria

• Suspected or proven bacterial infection at emergency department triage

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Proportion of patients who receive a first dose of antimicrobial agent	one hour	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who receive a first dose of adequate antimicrobial agent	three hours	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
In-hospital mortality at day 7	seven days	Number of patients who died in hospital at day 7
Proportion of patients who receive a first dose of antimicrobial agent	three hours	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.
Proportion of patients with a decrease in SOFA score value ≥ 1 point	two days	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
Proportion of patients requiring an admission to the Intensive Care Unit	two days	Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2
Length of hospital stay	throught hospital discharge, up to 3 months	Number of days in hospital
Overall In-hospital mortality	through hospital discharge, up to 3 months	Number of patients who died in hospital during the hospital stay

Trial Locations

Locations (1)

Regional Hospital center of Orleans; 🇫🇷 Orléans, France