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临床试验/NCT01213511
NCT01213511已完成不适用

Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation

AHEPA University Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Neurocognitive outcome at 3-month follow-up

研究概览

简要总结

The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC) extracorporeal circulation on neurocognitive function after elective coronary bypass grafting (CABG) as well as whether this can be attributed to improved cerebral perfusion intraoperatively.

详细描述

Despite improvements in the biocompatibility of cardiopulmonary bypass (CPB) circuits, the activation of inflammatory systemic response can result in clinically relevant organ dysfunction. Regarding the central nervous system, prolonged hypoperfusion and microembolization during conventional CPB have been related to postoperative neurologic impairment with an incidence varying from 30% to 60%. This clinical scenario covers a spectrum from a transient subtle cognitive dysfunction to a permanent stroke. Postoperative cognitive decline (POCD) is characterized as impairment in attention, cognition, recognition, orientation, memory, and learning. It may result in prolonged hospitalization, increased morbidity and mortality, while it has an adverse impact on quality of life after surgery.

Near-infrared spectroscopy (NIRS) provides a continuous and noninvasive monitoring of regional cerebral oxygen saturation (rSO2). Recent studies have shown a significant relationship between intraoperative cerebral oxygen desaturation, indicative of cerebral ischemia, and early POCD in patients undergoing elective coronary bypass grafting (CABG) with conventional extracorporeal circulation (CECC). In an attempt to reduce CPB-inherent side effects, a minimal extracorporeal circulation (MECC) system was developed and it is evaluated in clinical practice. The aim of this pilot study was to define whether there is a difference in early postoperative neurocognitive functioning between patients being operated for CABG on MECC versus CECC systems as well as whether this can be attributed to improved cerebral perfusion intraoperatively.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients scheduled for elective coronary artery bypass grafting

排除标准

  • history of psychiatric disorder
  • inability to undergo neuropsychological assessment
  • history of transient ischemic attack or stroke
  • carotid artery stenosis > 60% assessed by duplex ultrasonography

研究组 & 干预措施

MECC Group

Active Comparator

Patients operated for elective coronary artery bypass grafting with the use of minimal extracorporeal circulation.

干预措施: Coronary artery bypass grafting with the use of minimal extracorporeal circulation (Procedure)

CECC Group

Active Comparator

Group of patients undergoing elective coronary bypass grafting with the use of conventional extracorporeal circulation.

干预措施: Coronary artery bypass grafting under conventional extracorporeal circulation (Procedure)

结局指标

主要结局

Neurocognitive outcome at 3-month follow-up

时间窗: 3 months

Neurocognitive outcome at 3-month follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.

次要结局

  • Neurocognitive outcome at discharge(7-30 days)
  • Episodes of intraoperative cerebral desaturation(During the operation)

研究者

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

Kyriakos Anastasiadis

Head of Cardiothoracic Department

AHEPA University Hospital

研究点 (2)

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