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临床试验/NCT06066736
NCT06066736已完成不适用

Risks Factors and Outcome of Recurrences in Patients With Ventilator-Associated Pneumonias (REVAP)

Société Française d'Anesthésie et de Réanimation1 个研究点 分布在 1 个国家目标入组 1,569 人开始时间: 2023年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,569
试验地点
1
主要终点
Mortality at 28 days

研究概览

简要总结

Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. This nosocomial infection is associated with the highest mortality, ranging from 24% to 76% depending on the series. Reducing the incidence of VAP remains a challenge for clinicians, as evidenced by the many recent recommendations that have led to "bundles" to prevent the onset of this complication. Despite this, these recommendations do not propose a strategy to prevent the recurrence of PAVM, a frequent entity with a reported incidence of 25-35% and a non-consensual definition that increases antibiotic consumption, duration of mechanical ventilation and length of stay in the ICU .

In fact, these recurrences can be linked to:

  • Intrinsic patient risk factors (immunosuppression, severity of disease, major inflammatory response, reason for initial admission),
  • Inappropriate initial antibiotic therapy (type, duration and dose administered),
  • Characteristics specific to the pathogens encountered (virulence factors or resistance),
  • Intercurrent complications during management of the initial pneumonia (ARDS, abscess, pleural empyema).

Given the frequency of these recurrences, and the persistent doubts about the role of terrain and pathogen characteristics in their genesis, it seems appropriate to look at risk factors that could help anticipate these events.

The aim of our study will be to identify the risk factors and mortality associated with the occurrence of a recurrence of VAP in patients hospitalized in the intensive care unit.

An essential first step in this work will be to identify and then use the most consensual definition of recurrence of VAP, encompassing recurrence, persistence and superinfection. We will use the definitions in the protocol for the ASPIC trial, which is currently undergoing enrolment.

The second step is to identify risk factors for recurrence. By identifying these factors, it could be possible to propose a prognostic score that would enable careful monitoring (or modification of antibiotic therapy) of patients most at risk of recurrence. Such a score could then be evaluated in a prospective study.

详细描述

Ventilator-associated pneumonia (VAP) is a frequent and serious complication in the ICU, defined by the development of a lung infection in patients ventilated for more than 48 hours. The incidence rate of this condition exceeds 18 episodes per 1000 days of mechanical ventilation in Europe. This nosocomial infection is associated with the highest mortality, ranging from 24% to 76% depending on the series. Reducing the incidence of VAP remains a challenge for clinicians, as evidenced by the many recent recommendations that have led to "bundles" to prevent the onset of this complication. Despite this, these recommendations do not propose a strategy to prevent the recurrence of PAVM, a frequent entity with a reported incidence of 25-35% and a non-consensual definition that increases antibiotic consumption, duration of mechanical ventilation and length of stay in the ICU (1,2).

In fact, these recurrences can be linked to:

  • Intrinsic patient risk factors (immunosuppression, severity of disease, major inflammatory response, reason for initial admission),
  • Inappropriate initial antibiotic therapy (type, duration and dose administered),
  • Characteristics specific to the pathogens encountered (virulence factors or resistance),
  • Intercurrent complications during management of the initial pneumonia (ARDS, abscess, pleural empyema).

Given the frequency of these recurrences, and the persistent doubts about the role of terrain and pathogen characteristics in their genesis, it seems appropriate to look at risk factors that could help anticipate these events.

The aim of our study will be to identify the risk factors and mortality associated with the occurrence of a recurrence of VAP in patients hospitalized in the intensive care unit.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • Adult patient
  • Having presented an episode of ventilator-associated pneumonia defined as the association in a patient undergoing invasive mechanical ventilation ≥ 48h:
  • Radiological signs: two successive chest X-rays showing new or progressive pulmonary infiltrates (in the absence of a medical history of underlying heart or lung disease, a single chest X-ray is sufficient).
  • And at least one of the following signs:
  • Fever > 38.0˚ C without any other cause
  • Leukocytes < 4 × 109 l-1 or > 12 × 109 l-1
  • And at least two of the following signs:
  • Purulent tracheobronchial secretions
  • Cough or dyspnea
  • Decreased oxygenation or increased oxygen requirements, or need for respiratory assistance
  • Patient does not object to the use of his/her data for this research

排除标准

  • Opposition to the use of personnal data
  • People under legal protection (curatorship, guardianship) or safeguard of justice

结局指标

主要结局

Mortality at 28 days

时间窗: 28 days after ICU admission

Mortality at 28 days, verify if patient died 28 days after Ventilator-associated pneumonia

次要结局

  • Number of Ventilator-associated pneumonia recurrences(During inclusion period (from 01JAN2021 to 31DEC2022))
  • Number of days without mechanical ventilation at day 28(28 days after ICU admission)
  • Number of days without renal replacement therapy at day 28(28 days after ICU admission)
  • Number of days without catecholamines at day 28(28 days after ICU admission)
  • Number of days without antibiotics at day 28(28 days after ICU admission)
  • Length of stay in intensive care unit(During inclusion period (from 01JAN2021 to 31DEC2022))
  • MDR acquisition rate(During ICU stay)
  • Number of persistent Ventilator-associated pneumonia(During inclusion period (from 01JAN2021 to 31DEC2022))
  • Length of hospital stay(During inclusion period (from 01JAN2021 to 31DEC2022))
  • Number of superinfections of Ventilator-associated pneumonia(During inclusion period (from 01JAN2021 to 31DEC2022))

研究者

发起方
Société Française d'Anesthésie et de Réanimation
申办方类型
Other
责任方
Sponsor

研究点 (1)

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