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

NCT ID: NCT03299894

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 780 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-12
• Study Completion Date: 2018-06-10

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

systematic calculation of qSOFA

Intervention Type: PROCEDURE

calculation of qSOFA for each patient

no systematic calculation of qSOFA

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

systematic calculation of qSOFA

calculation of qSOFA for each patient

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 105 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien PASSERIEUX, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Hospital Center of Orleans

Locations

Regional Hospital center of Orleans

Orléans, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 26903338 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31103379 (View on PubMed)

Other Identifiers

CHRO 2017-06

Identifier Type: -

Identifier Source: org_study_id