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临床试验/NCT04214145
NCT04214145已完成不适用

The Effect of Phenylephrine, Norepinephrine and Vasopressin on Cerebral Oxygentaion During Off Pump CABG: A Pilot Study

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年1月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
1
主要终点
Cerebral oxygen saturation (%)

研究概览

简要总结

The purpose of this study is to analyze the changes in cerebral oxygen saturation during the use of three vasopressors, phenylephrine, norepinephrine, and vasopressin, which are currently used during coronary artery bypass grafting.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Patients undergoing off pump coronary artery bypass.

排除标准

  • Patient refusal
  • Preoperative vasopressor use
  • Preoperative mechanical circulatory support
  • Concurrent cerebrovascular or head and neck surgery
  • Technical difficulty of measuring brain oxygen saturation
  • Redo coronary artery bypass surgery

研究组 & 干预措施

Phenylephrine

Experimental

干预措施: Phenylephrine (Drug)

Norepinephrine

Experimental

干预措施: Norepinephrine (Drug)

Vasopressin

Experimental

干预措施: Vasopressin (Drug)

结局指标

主要结局

Cerebral oxygen saturation (%)

时间窗: during surgery

continuous monitoring of cerebral oxygen saturation during surgery

次要结局

  • NGAL(during surgery, at ICU admission, 24 hours / 48 hours after ICU admission)
  • MACCE(until 1 year after surgery)
  • blood pressure(during surgery)
  • heart rate(during surgery)
  • cardiac index(during surgery)
  • Total amount of infused drug(during surgery)
  • Input/output(during surgery)
  • Sublingual microscopy(1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure)
  • Vascular occlusion test(1) After induction, 2) lateral wall or posterior wall anastomosis (if possible) 3) skin closure)
  • Troponin I(during surgery, at ICU admission, 24 hours / 48 hours after ICU admission)
  • lactate(during surgery, at ICU admission, 24 hours / 48 hours after ICU admission)
  • creatinine(during surgery, at ICU admission, 24 hours / 48 hours after ICU admission)
  • albumin(during surgery, at ICU admission, 24 hours / 48 hours after ICU admission)
  • AKI/RRT(until 1 year after surgery)

研究者

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

Yunseok Jeon

Professor

Seoul National University Hospital

研究点 (1)

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