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

NCT01083784 | Unknown Phase 4

• 1 other identifier: 2009-08-038
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Cardiac arrest; Prophylactic anticonvulsant

Outcome Measures

Primary Outcomes (1)

• electroencephalogram (EEG)

  Seizure activity will be measured by EEG EEG will be interpreted by Nerologist

  72hr after cardiac arrest

Secondary Outcomes (1)

• CPC score (cerebral performance category) score

  1month and 3 month after cardiac arrest

Study Arms (2)

Prophylactic group

EXPERIMENTAL

the group that used prophylactic anticonvulsants (valproate, clonazepam)

Drug: Use of prophylactic anticonvulsants (valproate, clonazepam)

Control group

NO INTERVENTION

control group

Drug: Control group

Interventions

Use of prophylactic anticonvulsants (valproate, clonazepam) DRUG

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

Prophylactic group

Control group DRUG

Control group

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Interventions

Valproic Acid; Clonazepam; Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids; Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Min Seob Sim, Master

  Dept. of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2010
• First Posted: March 10, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Last Updated: July 25, 2011

Record last verified: 2011-07

Locations

KR (1)