Cardiac Arrest
Conditions
Keywords
Cardiac arrest, Prophylactic anticonvulsant
Brief summary
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.
Interventions
DRUGUse of prophylactic anticonvulsants (valproate, clonazepam)
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
DRUGControl group
Control group
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| electroencephalogram (EEG) | 72hr after cardiac arrest | Seizure activity will be measured by EEG EEG will be interpreted by Nerologist |
Secondary
| Measure | Time frame |
|---|---|
| CPC score (cerebral performance category) score | 1month and 3 month after cardiac arrest |
Countries
South Korea
Outcome results
None listed