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临床试验/NCT02916069
NCT02916069Unknown不适用

The Impact Multi Modal Brain Monitoring on Patient Out Come After Adult Cardiac Surgery

Assiut University2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,200
试验地点
2
主要终点
S100 protein

研究概览

简要总结

Multimodal brain monitoring is feasible and can be used in formulating therapeutic strategies during cardiac surgery. Such monitoring may help to improve patient outcome and to reduce costs after cardiac surgery with CPB.

详细描述

The aim of this study is to use a combination of brain monitoring {Nearinfrared Spectroscopy (NIRS), Transcranial Doppler (TCD), bispectral index (BIS)} to formulate therapeutic strategies based on these monitors and to evaluate the impact on patient outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Elective cardiac surgery with cardiopulmonary bypass
  • Valve replacement
  • Coronary artery bypass

排除标准

  • Emergency surgery
  • Renal impairment
  • Diabetes Mellitus

结局指标

主要结局

S100 protein

时间窗: up to 24 hours

S100 protein (marker of brain injury)

次要结局

  • Major neurological out come as stoke(up to 30 days after surgery)
  • Mini-mental state examination(up to 30 days after surgery)
  • Duration of mechanical ventilation(up to 30 days after surgery)
  • Hospital stay(up to 30 days after surgery)
  • Western perioperative neurological scale(up to 30 days after surgery)

研究者

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

Dr Mohamed Shaaban Ali, PhD, MD

Associate Professor (Anesthesiology and Critical Care)- College of Medicine-Assiut University

Assiut University

研究点 (2)

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