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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| systematic calculation of qSOFA | Procedure | calculation of qSOFA for each patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
• Suspected or proven bacterial infection at emergency department triage
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julien PASSERIEUX, MD | Regional Hospital Center of Orleans | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Hospital center of Orleans | Orléans | 45067 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26903338 | Background | 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. | |
| 31103379 |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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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):
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| 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 |
| 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 |
| 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 |
| 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 |
| In-hospital mortality at day 7 | Number of patients who died in hospital at day 7 | seven days |
| Overall In-hospital mortality | Number of patients who died in hospital during the hospital stay | through hospital discharge, up to 3 months |
| Length of hospital stay | Number of days in hospital | throught hospital discharge, up to 3 months |
| Derived |
| 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. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D020969 | Disease Attributes |