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

Intensive Care Clinical Trial

— qSOFAST  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299894
• Other study ID #: CHRO 2017-06
• Status: Completed
• Phase: N/A
• Start date: October 12, 2017
• Est. completion date: June 10, 2018

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 780
• Est. completion date: June 10, 2018
• Est. primary completion date: June 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infection
• Bacterial Infections
• Emergencies
• Infection
• Intensive Care

Intervention

Procedure:
• systematic calculation of qSOFA
calculation of qSOFA for each patient

Locations

Country	Name	City	State
France	Regional Hospital center of Orleans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	one hour
Secondary	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.	one hour
Secondary	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.	three hours
Secondary	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	three hours
Secondary	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	two days
Secondary	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	two days
Secondary	In-hospital mortality at day 7	Number of patients who died in hospital at day 7	seven days
Secondary	Overall In-hospital mortality	Number of patients who died in hospital during the hospital stay	through hospital discharge, up to 3 months
Secondary	Length of hospital stay	Number of days in hospital	throught hospital discharge, up to 3 months