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

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ClinicalTrials.gov Identifier: NCT03299894
Recruitment Status : Completed
First Posted : October 3, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Bacterial Infection Intensive Care Procedure: systematic calculation of qSOFA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 780 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 12, 2017
Actual Primary Completion Date : June 10, 2018
Actual Study Completion Date : June 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Procedure: systematic calculation of qSOFA
calculation of qSOFA for each patient

No Intervention: 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.



Primary Outcome Measures :
  1. Proportion of patients who receive a first dose of antimicrobial agent [ Time Frame: 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 :
  1. Proportion of patients who receive a first dose of adequate antimicrobial agent [ Time Frame: one hour ]
    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.

  2. Proportion of patients who receive a first dose of antimicrobial agent [ Time Frame: 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.

  3. Proportion of patients who receive a first dose of adequate antimicrobial agent [ Time Frame: 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

  4. Proportion of patients with a decrease in SOFA score value ≥ 1 point [ Time Frame: 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

  5. Proportion of patients requiring an admission to the Intensive Care Unit [ Time Frame: two days ]
    Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2

  6. In-hospital mortality at day 7 [ Time Frame: seven days ]
    Number of patients who died in hospital at day 7

  7. Overall In-hospital mortality [ Time Frame: through hospital discharge, up to 3 months ]
    Number of patients who died in hospital during the hospital stay

  8. Length of hospital stay [ Time Frame: throught hospital discharge, up to 3 months ]
    Number of days in hospital



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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299894


Locations
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France
Regional Hospital center of Orleans
Orléans, France, 45067
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
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Principal Investigator: Julien PASSERIEUX, MD Regional Hospital Center of Orleans

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT03299894     History of Changes
Other Study ID Numbers: CHRO 2017-06
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Régional d'Orléans:
Sepsis
Shock, septic
Emergency service, hospital
Anti-infective agents
Outcome assessment

Additional relevant MeSH terms:
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Infection
Bacterial Infections
Emergencies
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents