跳至主要内容
临床试验/NCT03931499
NCT03931499Unknown不适用

Biochemical Predictors of Delirium in Patients Undergoing Cardiac Surgery Under Cardiopulmonary Bypass

Meshalkin Research Institute of Pathology of Circulation1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Postoperative delirium

研究概览

简要总结

Delirium is a common neurologic complication after cardiac surgery occuring in 30-50% of patients. The occurence of this complication is associated with worse outcomes, including prolonged length of stay in the ICU and hospital, increased morbidity and mortality. Considering great clinical significance of this complication, the search for early predictors of postoperative delirium remains an urgent task. The purpose of this prospective observational study is to test the hypothesis that metabolomic changes before and after cardiac surgery could be served as early predictors of this complication.

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
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • surgery under cardiopulmonary bypass
  • Age > 60 years
  • CABG surgery or valve surgery (repair/replacement)

排除标准

  • urgent surgery
  • surgery on aorta
  • combined procedures (CABG+valves)
  • significant stenosis of carotid arteries
  • Parkinson's disease
  • liver cirrhosis
  • use of anticholinergic drugs, antidepressants, antiepileptic or chemotherapy drugs

结局指标

主要结局

Postoperative delirium

时间窗: 5 days after surgery

Postoperative delirium will be diagnosed with CAM-ICU (confusion assessment method - intensive care unit)

次要结局

未报告次要终点

研究者

发起方
Meshalkin Research Institute of Pathology of Circulation
申办方类型
Network
责任方
Sponsor

研究点 (1)

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