跳至主要内容
临床试验/NCT03299894
NCT03299894已完成不适用

Usefulness of Routine qSOFA Calculation at Triage to Fasten Antimicrobial Administration in Patients With Bacterial Infection in the Emergency Department: a Quasi-experimental Study

Centre Hospitalier Régional d'Orléans2 个研究点 分布在 1 个国家目标入组 780 人开始时间: 2017年10月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
780
试验地点
2
主要终点
Proportion of patients who receive a first dose of antimicrobial agent

研究概览

简要总结

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).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 105 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Suspected or proven bacterial infection at emergency department triage

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: systematic calculation of qSOFA (Procedure)

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.

结局指标

主要结局

Proportion of patients who receive a first dose of antimicrobial agent

时间窗: 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.

次要结局

  • Proportion of patients who receive a first dose of adequate antimicrobial agent(three hours)
  • In-hospital mortality at day 7(seven days)
  • Proportion of patients who receive a first dose of 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)
  • Length of hospital stay(throught hospital discharge, up to 3 months)
  • Overall In-hospital mortality(through hospital discharge, up to 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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