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临床试验/NCT04194411
NCT04194411已完成不适用

Association of Plasma Biomarkers for Neurological Injury and Postoperative Delirium After Cardiac Surgery

Yonsei University1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2020年1月7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
152
试验地点
1
主要终点
Postoperative delirium

研究概览

简要总结

Delirium is one of the most common complications after cardiac surgeries, incidence of which is 20~70%. Causes and pathophysiology of delirium has not been elucidated yet, however, inflammatory response of the nervous system, imbalance of neurotransmitters and ischemia-reperfusion injury of brain tissue are thought to play a big role.

'Neurofilament light (Nfl)' and 'Tau' are proteins that comprise neurons, which are released into blood during acute brain injury. Increased serum concentrations of these markers are acknowledged to be associated with worse clinical outcomes in patients with acute brain injury. These proteins are also closely linked to degenerative changes in the nervous system and cognitive decline in Alzheimer's disease. Therefore, the increase in blood levels of 'Nfl' and 'Tau' may be related to the development of delirium.

The aim of this study is to investigate the association between 'Nfl' and 'Tau', serum markers of damage of the nervous system, and the development of delirium after cardiac surgery.

详细描述

  1. Assessment of cognitive function and delirium Before the day before surgery, K-MMSE (Korean version of Mini-Mental State Exam) is conducted to check the subjects' baseline cognitive function.

From the postoperative day 0 to 7, CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) for mechanically ventilated patients, or 3D-CAM (3-minute diagnostic assessment for delirium using the Confusion Assessment Method) for extubated patients is performed twice a day to assess whether delirium occurs. Records of the nurses are also checked. 2. Measurement of the serum levels of Nfl and Tau Serum concentrations of Nfl and Tau are measured after anesthetic induction, and at postoperative 6 hours

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing valvular heart surgery (>65 years old)

排除标准

  • Emergency operation
  • Patients with drug or alcohol abuse
  • Patients with major depressive disorder, major neurocognitive disorder or schizophrenia
  • Patients with schizophrenia
  • Patients who are not able to communicate verbally

结局指标

主要结局

Postoperative delirium

时间窗: Postoperative 7 days

From the postoperative day 0 to 7, CAM-ICU (for mechanically ventilated patients) or 3D-CAM (for extubated patients) is performed twice a day. Electronic medical records of the patients are also assessed.

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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