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临床试验/NCT02722460
NCT02722460已完成不适用

Prospective Registry of Cardiopulmonary Arrest Survivors - Surrogate Markers for Prognostication of Outcome After Cardiac Arrest

Matthias Haenggi1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
incidence of survival

研究概览

简要总结

The aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These patients are comatose. Conscious patients are unsuitable for prognostication.

详细描述

The aim of the study is to determine surrogate markers for prognostication of unfavorable outcome (death or persistent vegetative state) in cardiopulmonary arrest survivors. These patients are comatose. Conscious patients are unsuitable for prognostication.

This will be a prospective mono-center survey (Department of Intensive Care Medicine, University Hospital Bern), evaluating the survival and neurological outcome after cardiac arrest. The study will be performed in cooperation with the Department of Neurology and Neuroradiology, University Hospital Bern.

Inclusion: all patients surviving resuscitation after cardiac arrest older than 18 years. Detailed medical and neurological examination including 6-lead continuous EEG, 10/20 EEG and somatosensory evoked potentials, standard blood tests including Neuron-specific Enolase (NSE) and cerebral MRI will be assessed during the first 72 hours after cardiac arrest. Structured telephone interviews to determine outcome parameters (Cerebral Performance Category CPC, modified Ranking Scale mRS) will take place at day 30, after 3 and 12 month.

The results of the registry could identify early comatose patients after cardiac arrest with no chance of a good neurological recovery and regain consciousness to avoid unjustified expectations of relatives and prolonged life-sustaining therapies. A good neurological recovery is defined as a CPC of 1 and 2 or a mRS 0-2. An unfavourable neurological outcome will be defined as persistent vegetative state and death (CPC 4 and 5, mRS 5-6).

研究设计

研究类型
Observational
观察模型
Case Only
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

  • Age at least 18 years
  • Down time ≤ 20 minutes (down time = time breakdown to start of professional resuscitation)
  • Persistent stable circulation without further need of CPR
  • Glasgow Coma Scale < 8 after return of spontaneous circulation

排除标准

  • Cardiac arrest due to neurological causes (stroke, intracerebral hemorrhage, subarachnoid hemorrhage, SUDEP - sudden unexpected death in epilepsy)
  • Cardiac arrest due to unobserved asystole

结局指标

主要结局

incidence of survival

时间窗: 30 days after CPR

incidence of patients still alive 30 days after cardiac arrest or patients discharged alive from hospital

次要结局

  • incidence of unfavorable outcome after cardiac arrest according to Cerebral Performance Categories Scale(72 hours after CPR)
  • Number of Patient with a low voltage EEG, defined as amplitude below 20 microvolt more than 24 to 72 hours after resuscitation.(up to 72 hours after CPR)
  • Number of patients with a Cut-off Value of Neuron specific enolase >/= 33 ug/l 72 hours after resuscitation(72 hours after CPR)
  • Number of patient with a burst suppression EEG more than 24 to 72 hours after resuscitation(up to 72 hours after CPR)
  • Number of patients with an isoelectric EEG more than 24 to 72 hours after resuscitation(up to 72 hours after CPR)

研究者

发起方
Matthias Haenggi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Matthias Haenggi

Attending Physician, Departement of Intensive Care Medicine

Insel Gruppe AG, University Hospital Bern

研究点 (1)

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