The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia
Recruitment status was: Enrolling by invitation
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.
|Cardiac Arrest||Drug: Use of prophylactic anticonvulsants (valproate, clonazepam) Drug: Control group||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Official Title:||The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia|
- electroencephalogram (EEG) [ Time Frame: 72hr after cardiac arrest ]Seizure activity will be measured by EEG EEG will be interpreted by Nerologist
- CPC score (cerebral performance category) score [ Time Frame: 1month and 3 month after cardiac arrest ]
|Study Start Date:||March 2010|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Prophylactic group
the group that used prophylactic anticonvulsants (valproate, clonazepam)
Drug: Use 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
No Intervention: Control group
Drug: Control group
Please refer to this study by its ClinicalTrials.gov identifier: NCT01083784
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Min Seob Sim, Master||Dept. of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine|