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临床试验/NCT03006484
NCT03006484已完成不适用

Neurological Outcomes After In-hospital Cardiac Arrest: a Prospective Observational Study

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 322 人开始时间: 2017年3月21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
322
试验地点
1
主要终点
Cerebral Performance Category(CPC) score of 1-2

研究概览

简要总结

Little is known about the long-term neurological outcomes after in-hospital cardiac arrest (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence rates of survivors with poor neurological status. Currently, withdrawal of care in comatose patients after cardiac arrest is strongly forbidden by law in Korea. However, a new legislation on allowing withdrawal of care will come into effect since early 2018 in Korea. The investigators aim to determine 1) long-term neurological outcomes in patients who developed IHCA, 2) whether early neurological status can predict late neurological status after IHCA, and 3) whether the proportion of IHCA survivors with good neurological outcomes will change since implementation of new legislation on withdrawal of care.

详细描述

<The schedule of assessment>

  • Day 0: Neurological examination (First examination will be performed within 2 hours after IHCA)
  • Day1 - 7: Neurological examination
  • Day7, 14, 21, 28: Neurological examination, CPC score
  • Day90: CPC score, survival
  • Day180: CPC score, survival
  • Day 360: CPC score, survival

<Cerebral Performance Category(CPC) score>

  • CPC 1: good cerebral performance
  • CPC 2: Moderate cerebral disability(available for independent activities)
  • CPC 3: Severe cerebral disability(dependent on others for daily support)
  • CPC 4: Coma or vegetative state
  • CPC 5: Brain death or death

<Acronyms>

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In-hospital cardiac arrest
  • Cardiopulmonary Resuscitation(CPR) code activation and/or neurology consultation for IHCA

排除标准

  • Neither (CPR) code activation nor neurology consultation
  • Development of IHCA during transition period

结局指标

主要结局

Cerebral Performance Category(CPC) score of 1-2

时间窗: 12 month after In-Hospital Cardiac Arrest(IHCA)

CPC score is the most universal index to assess neurological outcome following cardiac arrest. CPC score is classified according to the point. Good neurological outcome is defined as CPC 1-2 and poor is CPC 3-5. CPC score will be evaluated by neurological examination and the results of other exam. * Neurological examination: Neurologist will perform directly until the point of CPC score 1 is confirmed. 1. mental status: ACDU score, FOUR score and Glasgow Coma Scale 2. brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes 3. motor status * Responsive state: Medical Research Council grade * Unresponsive state: motor response to painful stimuli) 4. seizure evaluation: status myoclonus , seizure, status epilepticus * The result of other examinations in accordance with medical treatment guideline will be evaluated as well. (e.g. Finding MRI of the brain, EEG, neuron specific enolase)

次要结局

  • Mortality(Day 0-28, 3 month, 6 month, and 12 month after IHCA)
  • Awakening(Day 0-28 after IHCA)
  • CPC score(Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA)
  • Neurological recovery(Day 0-28 after IHCA)

研究者

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

Sang-Beom Jeon

Associate Professor

Asan Medical Center

研究点 (1)

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