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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01083784
First received: March 7, 2010
Last updated: July 21, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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 July 26, 2014