A multicenter, randomized, blinded, comparative effectiveness study of fosphenytoin, valproic acid, or levetiracetam in the emergency department treatment of patients with benzodiazepine-refractory status epilepticus
Study ID: STU 012015-020
This is a multicenter, randomized, Bayesian response-adaptive comparative effectiveness trial of three active treatments in patients with established Se who have failed treatment with benzodiazepines. Subjects will initially be randomized in a 1:1:1 ratio. Patients will be included in this study if they are aged 2 or older, have been treated for generalized convulsive seizure of greater than 5 minutes duration with adequate doses of benzodiazepines, and who continue to have persistent or recurrent convulsions in the emergency department at least 5 minutes and no more than 30 minutes after the last dose of benzodiazepine. The primary outcome is clinical cessation of status epilepticus, determined by the absence of clinically apparent seizures and improving responsiveness, at 60 minutes after the start of study drug infusion, without the use of additional anti-seizure medication. The following are secondary outcomes: occurrence of life threatening hypotension or cardiac arrhythmia, time to termination of seizures, intubation, admission to iCu, seizure recurrence, length of stay in the iCu and hospital, mortality, and Richmond agitation and sedation score at 60 minutes, will be compared between treatment groups.
1. Patients age 2 years or older 2. Patient witnessed to seize for greater than 5 minute duration prior to treatment with study drug. 3. Patient received adequate dose of benzodiazepines. The last dose of a benzo was administered in the 5-30 minutes prior to study drug administration. 4. Continued or recurring seizure in CMC-Dallas Emergency Department.