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临床试验/NCT01083784
NCT01083784Unknown4 期

The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
60
试验地点
1
主要终点
electroencephalogram (EEG)

研究概览

简要总结

Cardiac arrest is a leading cause of sudden death, but the survival rate of cardiac arrest is only 5-35%.

Although, the first resuscitation of cardiac arrest patient would be success, the hypoxic brain injury after cardiac arrest is an important cause of the mortality and the morbidity.

For the management of the hypoxic brain injury after cardiac arrest, American Heart Association and European Resuscitation Council recommend induced mild hypothermia therapy. And, ILCOR(International Liaison Committee on Resuscitation) announced the standard treatment of post cardiac arrest syndrome(the success state of first resuscitation of the cardiac arrest patient) included the induced mild hypothermia therapy at September, 2008.

The generalized seizure and myoclonus arise in over 60% of post cardiac arrest syndrome patients and they are very difficult to control. Also, the occurrence of them implies poor prognosis of the patient.

Although, mild hypothermia therapy could be decrease the development and propagation of generalized seizure and myoclonus theologically, the therapy could not prevent the development and propagation of them entirely. Therefore, the use of prophylactic anticonvulsant should be needed. But, there is not randomized control study about the use of prophylactic anticonvulsant.

We hypothesized that the use of prophylactic anticonvulsant to post cardiac arrest syndrome patients would decrease the rate of occurrence of generalized seizure and myoclonus and would improve the neurologic outcome.

We planed that we used two anti-epileptic drugs - valproate, clonazepam - for the prophylactic anticonvulsant. The valproate and clonazepam are in general use for prevention and treatment of generalized seizure and myoclonus and are recommended to treat of generalized seizure and myoclonus to post cardiac arrest syndrome patients by 2008 guideline of ILCOR.

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
Single (Participant)

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

入选标准

  • Age : over 18, under 80
  • Witnessed arrest
  • Successful first resuscitation (ROSC should be last for 20 min.)
  • Coma or Semicoma state
  • Mean arterial pressure > 60mmHg
  • Peripheral Oxygen saturation > 85%
  • Expected life span before cardiac arrest > 3 month.
  • Performance scale before cardiac arrest > 3 month.

排除标准

  • Cause of arrest
  • Sepsis, Progression of malignancy, Trauma, Hemorrhagic shock
  • Known Coagulopathy
  • Major operation within 7 days
  • Previous seizure history
  • current use of valproate or clonazepam

研究组 & 干预措施

Prophylactic group

Experimental

the group that used prophylactic anticonvulsants (valproate, clonazepam)

干预措施: Use of prophylactic anticonvulsants (valproate, clonazepam) (Drug)

Control group

No Intervention

control group

干预措施: Control group (Drug)

结局指标

主要结局

electroencephalogram (EEG)

时间窗: 72hr after cardiac arrest

Seizure activity will be measured by EEG EEG will be interpreted by Nerologist

次要结局

  • CPC score (cerebral performance category) score(1month and 3 month after cardiac arrest)

研究者

申办方类型
Other

研究点 (1)

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