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

NCT03299894 | Completed

• 1 other identifier: CHRO 2017-06
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 1

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).

Conditions

Bacterial Infection; Intensive Care

Keywords

Sepsis; Shock, septic; Emergency service, hospital; Anti-infective agents; Outcome assessment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

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

  one hour

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

  three hours

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

  three hours

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

  two days

• Proportion of patients requiring an admission to the Intensive Care Unit

  two days

Study Arms (2)

systematic calculation of qSOFA

EXPERIMENTAL

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

Procedure: systematic calculation of qSOFA

no systematic calculation of qSOFA

NO INTERVENTION

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

Interventions

systematic calculation of qSOFA PROCEDURE

calculation of qSOFA for each patient

systematic calculation of qSOFA

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected or proven bacterial infection at emergency department triage

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

Regional Hospital center of Orleans

Orléans, 45067, France

Location

Related Publications (2)

• 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.

  PMID: 26903338 BACKGROUND

• 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.

  PMID: 31103379 DERIVED

MeSH Terms

Conditions

Bacterial Infections; Sepsis; Shock, Septic; Emergencies

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Disease Attributes

Study Officials

• Julien PASSERIEUX, MD

  Regional Hospital Center of Orleans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: October 3, 2017
• Study Start: October 12, 2017
• Primary Completion: June 10, 2018
• Study Completion: June 10, 2018
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

FR (1)