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临床试验/NCT03117712
NCT03117712已完成不适用

Influence of Cerebral Blood Supply During Cardiopulmonary Bypass on the Incidence of Postoperative Delirium in Open-heart Surgery

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年5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
40
试验地点
1
主要终点
cerebral blood flow

研究概览

简要总结

Postoperative delirium is an acute and fluctuating state of confusion and disorientation with an incidence of 25-70% after cardiac surgery. Possible reasons for this multifactorial complication are hypoperfusion, cerebral microembolization and inflammatory response, which eventually lead to regional or global imbalance between cerebral oxygen demand and supply. Adequate cerebral blood supply depends sufficient blood supply via the vertebral arteries and the internal carotid arteries. The aim of this preliminary study is to investigate if patients who develop delirium after open-heart surgery show differences in their cerebral blood flow during cardiopulmonary bypass (CPB) in extracerebral arterial vessels compared to those patients without delirium.

详细描述

Postoperative delirium is an acute and fluctuating state of confusion and disorientation, characterized by changes in attention, cognition, consciousness, and perception, with an incidence of 25-70% after cardiac surgery. Possible reasons for this multifactorial complication are hypoperfusion, cerebral microembolization and inflammatory response, which eventually lead to regional or global imbalance between cerebral oxygen demand and supply. This frequent cerebral injury has detrimental and long-lasting consequences and remains a serious healthcare burden, particularly due to its association with higher medical costs, increased morbidity, long-term cognitive deficits, and greater mortality. Progress in reducing the incidence of delirium has been hindered by the lack of a full understanding of its pathophysiology.

Adequate cerebral blood supply depends sufficient blood supply via the vertebral arteries and the internal carotid arteries. Whereby the blood supply of the brain by the carotid arteries is two-thirds and is easily accessable for blood flow examination with Doppler ultrasound.

The aim of this preliminary study is to investigate if patients who develop delirium after open-heart surgery show differences in their cerebral blood flow during cardiopulmonary bypass (CPB) in extracerebral arterial vessels compared to those patients without delirium. Additionally we want to investigate the influence of cerebral microembolisation and CPB associated inflammation in those patients. As secondary outcome measure we also want to determine differences in length of stay (LOS) in the intensive care unit (ICU) as well as in hospital LOS and 30-day mortality.

Methods:

Design:

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

入选标准

  • elective cardiac surgery valve replacement/reconstruction cardiopulmonary bypass

排除标准

  • Emergency procedures
  • Postoperative need for extracorporal cardiac assist device
  • Untreated or uncontrolled arterial hypertension
  • Profound hypothermic CPB (body temperature <34°C)
  • History of preoperative dementia
  • History of Stroke
  • Significant carotid artery stenosis
  • Age < 18 years
  • Chronic renal replacement therapy
  • Declined informed consent

结局指标

主要结局

cerebral blood flow

时间窗: during surgery

Differences in mean laminar cerebral blood flow on cardiopulmonary bypass during open heart surgery between patients with and without postoperative delirium

次要结局

  • HITS (high-intensity transient signals)(during surgery)

研究者

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

Ulrike Weber

Ass.Prof.Dr.

Medical University of Vienna

研究点 (1)

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