The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiac Arrest |
Drug: Use of prophylactic anticonvulsants (valproate, clonazepam) Drug: Control group |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2010 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
control group
|
Drug: Control group
Control group
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | MS SIM, MD, Dept.of emergency medicine, Assistant professor, Samsung Medical Center |
| ClinicalTrials.gov Identifier: | NCT01083784 History of Changes |
| Other Study ID Numbers: | 2009-08-038 |
| Study First Received: | March 7, 2010 |
| Last Updated: | July 21, 2011 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Samsung Medical Center:
|
Cardiac arrest Prophylactic anticonvulsant |
Additional relevant MeSH terms:
|
Heart Arrest Hypothermia Heart Diseases Cardiovascular Diseases Body Temperature Changes Signs and Symptoms Anticonvulsants Valproic Acid Clonazepam Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs GABA Modulators |
ClinicalTrials.gov processed this record on May 21, 2013