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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Drug: Use of prophylactic anticonvulsants (valproate, clonazepam)
* Drug: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic group<br>the group that used prophylactic anticonvulsants (valproate, clonazepam) | Drug: Use of prophylactic anticonvulsants (valproate, clonazepam)<br>* start at hypothermia induction valproate : 30mg/kg iv loading - 8hr after - 6mg/kg q 8hr iv till 72hr clonazepam : 1mg po bit via L-tube till 72 hr<br>|
| No Intervention: Control group<br>control group | Drug: Control group<br>* Control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electroencephalogram (EEG) | Seizure activity will be measured by EEG EEG will be interpreted by Nerologist | 72hr after cardiac arrest | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPC score (cerebral performance category) score |  | 1month and 3 month after cardiac arrest | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrest, Prophylactic anticonvulsant