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临床试验/NCT05448534
NCT05448534已完成不适用

Electroencephalographic Patterns of Septic Patients and Its Correlation With Cognitive Outcomes

Hospital Sao Domingos1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2021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
160
试验地点
1
主要终点
Electroencephalographic patterns

研究概览

简要总结

The investigators evaluated the electroencephalographic pattern by the Sinek and Young scales during ICU stay and its correlation with cognitive impairment determined by the Montreal Cognitive Assessment (MOCA) in septic patients after 3 months of ICU discharge..

详细描述

The investigators prospectively evaluate patients with sepsis and septic shock expected to stay in the intensive care unit (ICU) for at least 4 days. We used Sinek and Young scales to classify electroencephalographic patterns during ICU stay (in the first 24 hours after admission and in the third ICU day) and correlate with cognitive outcome evaluated with MOCA score 3 months after ICU discharge. The investigators evaluate as primary outcome the association between electroencephalographic abnormalities and cognitive dysfunction measured by the Montreal Cognitive Assessment (MoCA) 3 months after ICU discharge and secondary outcomes as association between electroencephalographic patterns and 28 days mortality, Quality of Life (SF-36) after 3 months of discharge, ventilator free days, vasoactive drug free days and Glasgow outcome scale.

研究设计

研究类型
Observational
观察模型
Cohort
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
否

入选标准

  • •Included were patients aged above 18 years, who were expected to stay in the ICU for at least 4 days, between November 2021 and November

排除标准

  • •CNS infections,
  • •Structural abnormalities of the CNS, known
  • •Liver or uremic encephalopathy,
  • •Advanced dementia (Mini mental < 9),
  • •Psychiatric disorder
  • •Epilepsy.

结局指标

主要结局

Electroencephalographic patterns

时间窗: 3 months after hospital discharge

Electroencephalographic patterns determined by Sinek and Young scales. The Synek outcome Scale ranges from normal (alpha dominant rhythm) to suppression (worst outcome). The scale assesses the outcome of patients with sepsis. Young's Scale Electroencephalographic classification of coma assesses outcome of patients with sepsis Outcome varies from normal (Delta/Theta Rhythm \> 50% of record). worst result Suppression The two scales are complementary.

Cognitive evaluation

时间窗: 3 months after hospital discharge

Cognitive dysfunction measured by Montreal Cognitive Assessment (MoCA)

次要结局

  • electroencephalographic patterns and 28 days mortality .(28 days)
  • Quality of Life (SF-36) after 3 months of discharge(3 months after hospital discharge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Raimundo Araujo de Azevedo

ICU Coordinator

Hospital Sao Domingos

研究点 (1)

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