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

Samsung Medical Center

Status and phase: Unknown; Phase 4

Conditions: Cardiac Arrest

Treatments: Drug: Control group; Drug: Use of prophylactic anticonvulsants (valproate, clonazepam)

Study type: Interventional

Funder types: Other

Identifiers

NCT01083784

2009-08-038

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Prophylactic group

Experimental group

Description:

the group that used prophylactic anticonvulsants (valproate, clonazepam)

Treatment:

Drug: Use of prophylactic anticonvulsants (valproate, clonazepam)

Control group

No Intervention group

Description:

control group

Treatment:

Drug: Control group