Japanease

Dec. 16, 2019

Oct. 14, 2020

jRCTs031190160

LevetIracetam vs. Fosphenytoine for status epilepticus: multi-center randomised non-blinded control trial (IENE ECT with LIFE)

Ibaraki ER Network Epilepsy Control Trial with LevetIracetam vs. FosphEnytoine (IENE ECT with LIFE)

Inoue Yoshiaki

University of Tsukuba Hospital

2-1-1 Amakubo Tsukuba Ibaraki

+81-29-853-3210

yinoue@md.tsukuba.ac.jp

Nakamura Kensuke

Hitachi General Hospital

2-1-1 Jonancho Hitachi Ibaraki

+81-294-23-1111

knakamura-tky@umin.ac.jp

Dec. 25, 2019

176

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

none

status epilepticus with convulsion, who were transfered by ambulance
The difinition of status epilepticus is as follows; over 5 minutes of continuous seizures, or over 2 minutes discrete seizures between which there is incomplete recovery of consciousness over JCS II-30
exclude non-convulsive seizure

under 20 years old
patients who entried this study in the past
patients in whom informed consent can not be obtained from proxies (If proxies can not be found, the study is performed and the consent is obtained after action.
already intubated patients before treatment
allergy to fosphenytoin or levetiracetam
pregnancy
pseudo-seizure
medical doctor considered inapropriate

20age old over
No limit

Both

status epilepticus

levetiracetam

At first, diazepam 1 - 20 mg is given in both groups.
Hosphenytoin group
After diazepam, hosphenytoin 22.5mg/kg+normal saline 100ml is given DIV by under 3mg/kg/min or 150mg/min
Levetiracetam group
After diazepam, levetiracetam 1000-3000mg is given DIV by 2-5mg/kg/min

status epilepticus

status epilepticus

seizure stop within 30 min from start of study drugs administration

seizure reccurence within 24 h
severe adverse events
intubation rate

Recruiting

Japanese Association for Acute Medicine
Not applicable
University of Tsukuba research ethics committee
1-1-1 Tennodai Tsukaba, Ibaraki

+81-29-853-3914

t-credo.adm@un.tsukuba.ac.jp
Approval

Sept. 20, 2019