Neurological Prognostication of Patients in Therapeutic Hypothermia After Cardiac Arrest
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Glasgow-Pittsburgh Cerebral Performance Categories (CPC) after 6 months
研究概览
简要总结
3500 people suffer from out of hospital cardiac arrest each year in Denmark. Therapeutic hypothermia to 33 degrees celsius is now standard treatment of comatose cardiac arrest patients. The investigators are challenged in our attempt to predict outcome of these patients by both low body temperature in itself and the sedative and relaxing drugs used to keep the patient in a coma.
This study is a substudy in a large international multicenter randomized trial that investigates the possible benefit of 48 hours of therapeutic hypothermia versus todays standard of 24 hours.
In this substudy the investigators will approach early prediction of neurological outcome using a combination of new examinations backed up by well established ones to engage this challenge from different angles and find a battery of combined examinations, that together will enable us to accurately predict outcome at an earlier stage.
Our examinations have been chosen from the three fields of neurophysiology, biochemistry and neurology and consist of electroencephalography (EEG), somatosensory evoked potentials (SEP), biomarkers and clinical examinations such as brain stem reflexes chosen for their prognostic reliability.
详细描述
Neurological prognostication of patients in therapeutic hypothermia after cardiac arrest
Background: In Denmark, approximately 3000 people suffer from cardiac arrest (CA) each year. After CA with no blood flow for more than five minutes, cerebral ischemia, free radicals along with other mediators creates chemical cascades during reperfusion that result in cerebral injury and often severe neurologic impairment.
Therapeutic hypothermia (TH) has become standard treatment of comatose CA patients and this has led to new challenges in the area of prognostication, because both the low temperature in itself and the sedative and relaxing drugs used to keep the patient in a coma, affect the examinations performed by the clinician.
This calls for a reevaluation of the existing prognostic examinations and the invention and implementation of new ones.
A new awareness towards a prognostic model involving several different modalities including SSEP, EEG, biomarkers and clinical examinations is thus awakening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Out-of-hospital cardiac arrest with presumable cardiac origin
- •Restored spontaneous circulation after resuscitation (No need for cardiac compressions during 20 min, and clinical sign of circulation)
- •Glasgow Coma Score (GCS) < 8
- •Age >= 18, < 80 years
排除标准
- •Estimated time interval from collapse to return of spontaneous circulation>60 min
- •Cardiac arrest with presumable non-cardiac origin (hypoxia etc.).
- •In hospital cardiac arrest
- •Terminal disease
- •Coagulopathy (anticoagulation treatment including thrombolysis is not an exclusion criteria)
- •Unwitnessed asystolia
- •Time from cardiac arrest to initiation of cooling>240 min.
- •Pregnancy
- •Persistent cardiogenic shock, systolic blood pressure<80 mmHg despite vasoactive treatment
- •Cerebral performance category (CPC) 3-4 before cardiac arrest.
- •Suspicious or confirmed intracerebral bleeding
- •Suspicious or confirmed acute stroke
- •Acute CABG
- •No informed consent from relatives
- •No informed consent from general practitioner
- •Patient unstable
- •Other reason
结局指标
主要结局
Glasgow-Pittsburgh Cerebral Performance Categories (CPC) after 6 months
时间窗: 6 months
To evaluate neurologic recovery using the Glasgow-Pittsburgh Cerebral Performance Categories (CPC) 6 months after cardiac arrest. The CPC-score will be dichotomized in good (CPC 1-2) and poor (CPC 3-5) outcome.
次要结局
- Area under the curve(72 hours)