|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01083784 |
|
Date of registration:
|
07/03/2010 |
|
Primary sponsor: |
|
|
Public title:
|
The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia
|
|
Scientific title:
|
The Benefit of Prophylactic Anticonvulsant in Post Cardiac Arrest Syndrome With Induced Mild Hypothermia |
|
Date of first enrolment:
|
March 2010 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Enrolling by invitation |
|
URL:
|
http://clinicaltrials.gov/show/NCT01083784 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Min Seob Sim, Master |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Dept. of Emergency Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Cardiac Arrest
|
|
Intervention(s)
|
|
Drug: Control group
|
|
Drug: Use of prophylactic anticonvulsants (valproate, clonazepam)
|
|
Primary Outcome(s)
|
|
electroencephalogram (EEG)
[Time Frame: 72hr after cardiac arrest]
|
|
Secondary Outcome(s)
|
|
CPC score (cerebral performance category) score
[Time Frame: 1month and 3 month after cardiac arrest]
|
|
Secondary ID(s)
|
|
2009-08-038
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|