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临床试验/NCT03737747
NCT03737747已完成不适用

The Performance of the Synek Score to Predict Poor Neurological Outcome in Postanoxic Comatose Patients Treated With Induced Hypothermia

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2013年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
The primary outcome is the CPC 3-5 score at 3 months or at death time

研究概览

简要总结

Resuscitated cardiac arrest (CA) is a frequent cause of admission in intensive care unit (ICU). Neurological state of postanoxic comatose patients can evolve either towards the absence of awakening or towards a more or less altered state of consciousness, ranging from the vegetative state to the full recovery of cognitive functions. Most of the deaths result from active withdrawal of life-sustaining treatment, based on poor neurological outcome prediction. Neurological prognostication needs therefore a multimodal approach based on reliable parameters, which should be easy to access and available at the early stage of care, in attempt to limit false poor outcome prognostication and help to not prolong futile active care in patient with severe post anoxic cerebral lesions. Nowadays the prediction of neurological outcome relies on a multimodal strategy including clinical examination, biomarkers and electroencephalography (Guidelines ESICM 2015). Early standard electroencephalography (EEG) is currently recommended and some features, notably absence of reactivity, status epilepticus or burst suppression after rewarming are strongly predictive of poor outcome. But those features require a precise analyze of the EEG usually performed by specialist. EEG patterns can be simplified and classified in five grades according to the Synek classification, ranging from dominant reactive alpha activity (grade 1) to isoelectric encephalogram (grade 5). Grade 1 and two are considering as good prognostic, grade 3 as intermediate and grade 4 to five as poor prognostic. Nevertheless, few data are available on the performance of this classification since generalization of TTM use.

We hypothesize that a multimodal strategy combining clinical examination, NSE concentration and the Synek score would bring a high degree of prediction. We aimed to assess the performances of the combination of clinical examination, NSE analysed at 48-72h and the Synek score to predict hard outcome defined by a cerebral performance category (CPC) 3-5, in postanoxic comatose patients treated with induced hypothermia

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

  • patients admitted in our ICU following a resuscitate cardiac arrest between November 1, 2013 to November 1, 2017
  • treated with 33° induced hypothermia for 24 h
  • having at least one early EEG rated according to Synek score
  • available dosage of NSE performed within 48-72h post CA

排除标准

  • moribund patients
  • awoke within the first 48 hours of admission
  • neurologic causes of CA
  • patients with missing data

结局指标

主要结局

The primary outcome is the CPC 3-5 score at 3 months or at death time

时间窗: at 3 months

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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