The established status epilepticus trial 2013.

摘要: Benzodiazepine-refractory status epilepticus (established epilepticus, ESE) is a relatively common emergency condition with several widely used treatments. There are no controlled, randomized, blinded clinical trials to compare the efficacy and tolerability of currently available treatments for ESE. The ESE treatment trial designed determine most effective and/or least among patients older than 2 years by comparing three arms: fosphenytoin (fPHT) levetiracetam (LVT), valproic acid (VPA). This multicenter, double-blind, Bayesian adaptive, phase III comparative effectiveness trial. Up 795 will be randomized initially 1:1:1, response-adaptive randomization occur after 300 have been recruited. Randomization stratified age groups, 2–18, 19–65, 66 older. primary outcome measure cessation seizure activity improving mental status, without serious adverse effects or further intervention at 60 min administration study drug. Each subject followed until discharge 30 days from enrollment. include interim analyses early success futility. considered if probability that >0.975 any treatment. Proposed total sample size 795, which provides 90% power identify when one arm has true response rate 65% 50% in other two arms.