跳至主要内容
临床试验/NCT03007862
NCT03007862Unknown不适用

Salivary Alpha Amylase Bronchial Measure for Early Aspiration Pneumonia Diagnosis in Patients Treated With Therapeutic Hypothermia After Out-of-hospital Cardiac Arrest.

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Early Aspiration Pneumonia

研究概览

简要总结

Early Aspiration Pneumonia is a frequent and dreadful complication in survivors of cardiac arrest. Therapeutic Hypothermia widely used in Intensive Care Unit for its benefice on post cardiac arrest syndrome may otherwise hide signs of early pneumonia that may occur without use of a reliable screening biological marker. The goal is to assess the diagnostic accuracy of bronchial alpha amylase measure to predict a risk of early aspiration pneumonia in patients successfully resuscitated after out-of-hospital cardiac arrest.

In this prospective non interventional study we included patients resuscitated after cardiac arrest and treated with Targeted Temperature Management (TTM). A distal bronchoalveolar lavage using specific display (Combi-Cath) was executed immediately after admission for each patient with both biochemic and bacteriological analysis including dosage of bronchial salivary alpha amylase. Urea was used as a marker of dilution in the measure of bronchial and plasmatic alpha amylase. Aspiration pneumonia diagnosis was established with clinical and biological criteria. On this basis we intended to determine a threshold measure of alpha amylase predicting occurrence of aspiration pneumonia and allowing a guidance in antibiotherapy prescription. Sensibility and Specificity of this technique were determined.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Well resuscitated patients after out-of-hospital cardiac arrest
  • Indication of Therapeutic Temperature Management
  • Patients aged over 18 years
  • Immediate or deferred acceptation of study

排除标准

  • Patients aged under 18 years.
  • Pregnant women.
  • Against indication to therapeutic hypothermia.
  • Active therapeutic limitation after admission.
  • Patient without social security.

结局指标

主要结局

Early Aspiration Pneumonia

时间窗: Within 5 days

Diagnosis of aspiration pneumonia after cardiac arrest with clinical, biological and radiological criteria including fever, leucocytes, broncho alveolar secretion, chest radiography and bacteriological identification.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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