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

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Use of prophylactic anticonvulsants (valproate, clonazepam)
Control group
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac arrest, Prophylactic anticonvulsant

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prophylactic group

Control group

Arm Description

the group that used prophylactic anticonvulsants (valproate, clonazepam)

control group

Outcomes

Primary Outcome Measures

electroencephalogram (EEG)
Seizure activity will be measured by EEG EEG will be interpreted by Nerologist

Secondary Outcome Measures

CPC score (cerebral performance category) score

Full Information

First Posted
March 7, 2010
Last Updated
July 21, 2011
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01083784
Brief Title
The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia
Official Title
The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Cardiac arrest, Prophylactic anticonvulsant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic group
Arm Type
Experimental
Arm Description
the group that used prophylactic anticonvulsants (valproate, clonazepam)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
control group
Intervention Type
Drug
Intervention Name(s)
Use of prophylactic anticonvulsants (valproate, clonazepam)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Control group
Intervention Description
Control group
Primary Outcome Measure Information:
Title
electroencephalogram (EEG)
Description
Seizure activity will be measured by EEG EEG will be interpreted by Nerologist
Time Frame
72hr after cardiac arrest
Secondary Outcome Measure Information:
Title
CPC score (cerebral performance category) score
Time Frame
1month and 3 month after cardiac arrest

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Min Seob Sim, Master
Organizational Affiliation
Dept. of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
Citation
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.
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The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia

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