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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01083784
Recruitment Status : Unknown
Verified July 2011 by Samsung Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : March 10, 2010
Last Update Posted : July 25, 2011
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Drug: Use of prophylactic anticonvulsants (valproate, clonazepam) Drug: Control group Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : March 2010
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Clonazepam
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. electroencephalogram (EEG) [ Time Frame: 72hr after cardiac arrest ]
    Seizure activity will be measured by EEG EEG will be interpreted by Nerologist


Secondary Outcome Measures :
  1. CPC score (cerebral performance category) score [ Time Frame: 1month and 3 month after cardiac arrest ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01083784


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Min Seob Sim, Master Dept. of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
More Information

Publications:
1. Willis, C.D., et al., Cardiopulmonary resuscitation after traumatic cardiac arrest is not always futile. Injury, 2006. 37(5): p. 448-54. 2. Eisenberg, M.S., et al., Cardiac arrest and resuscitation: a tale of 29 cities. Ann Emerg Med, 1990. 19(2): p. 179-86. 3. Edgren, E., et al., Assessment of neurological prognosis in comatose survivors of cardiac arrest. BRCT I Study Group. Lancet, 1994. 343(8905): p. 1055-9. 4. Nolan, J.P., et al., Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication.Resuscitation, 2008. 79(3): p. 350-79. 5. Neumar, R.W., et al., Post-cardiac arrest syndrome: epidemiology, pathophysiology, treatment, and prognostication. Circulation, 2008. 118(23): p. 2452-83. 6. Kuboyama, K., et al., Delay in cooling negates the beneficial effect of mild resuscitative cerebral hypothermia after cardiac arrest in dogs: a prospective, randomized study. Crit Care Med, 1993. 21(9): p. 1348-58. 7. Weinrauch, V., et al., Beneficial effect of mild hypothermia and detrimental effect of deep hypothermia after cardiac arrest in dogs. Stroke, 1992. 23(10): p. 1454-62. 8. Sterz, F., et al., Mild hypothermic cardiopulmonary resuscitation improves outcome after prolonged cardiac arrest in dogs. Crit Care Med, 1991. 19(3): p. 379-89. 9. Leonov, Y., et al., Mild cerebral hypothermia during and after cardiac arrest improves neurologic outcome in dogs. J Cereb Blood Flow Metab, 1990. 10(1): p. 57-70. 10. Bernard, S.A., et al., Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. N Engl J Med, 2002. 346(8): p. 557-63.

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
First Posted: March 10, 2010    Key Record Dates
Last Update Posted: July 25, 2011
Last Verified: July 2011

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
Valproic Acid
Clonazepam
Anticonvulsants
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