Prospective Registry of Cardiopulmonary Arrest Survivors - Surrogate Markers for Prognostication of Outcome After Cardiac Arrest
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
- 否
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
Matthias Haenggi
Attending Physician, Departement of Intensive Care Medicine
Insel Gruppe AG, University Hospital Bern
