Treatment of Established Status Epilepticus in the Elderly - a prospective, randomized, double-blind comparative effectiveness trial - ToSEE

niversität Leipzig0 个研究点目标入组 132 人开始时间: 2020年7月3日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Adult patients = 65 years old with ongoing convulsive SE (generalized CSE/focal CSE with impaired consciousness/focal CSE without impaired consciousness), as defined by a seizure lasting = 5 minutes or 2 or more convulsive seizures without full recovery of consciousness = 5 minutes, or nonconvulsive SE (NCSE with coma/ NCSE without coma) defined as ongoing EEG patterns consistent with definite or possible NCSE according to the Salzburg criteria (Leitinger et al. 2016), or clinically defined NCSE non-responding to treatment with AT LEAST
•- Lorazepam 2 mg (i.v.)
•- Midazolam 5 mg (i.v., buccal, intranasal, i.m.)
•- Diazepam 5 mg (i.v., rectal)
•- Clonazepam 1 mg (i.v.)

•- Treatment of SE with other antiepileptic drugs/sedatives before enrollment
•- Intravenous application of VPA or LEV in the last 24 hours before enrollment.
•- Known or suspected severe liver or pancreatic disease (alcohol addiction, known liver cirrhosis or familial liver diseases, clinical signs of severe liver disease such as ascites, jaundice)
•- Known concomitant treatment with one or several of the following medications: phenobarbital, phenytoin, carbamazepine, carbapenem antibiotics, rifampicin, erythromycin, cimetidine, primidone, mefloquine, fluoxetine, felbamat, lopinavir, ritonavir
•- Known coagulopathy (anticoagulants allowed)
•- Known porphyria, mitochondriopathy and urea cycle disorders
•- Known severe kidney disease (GFR < 30ml/min)
•- Hypoglycemia (< 3.3 mmol/l)
•- Estimated weight < 45kg.
•- Need for acute neurosurgical treatment.
•- Known cardiopulmonary resuscitation within the last 7 days before enrollment
•- Known hypersensitivity against VPA or LEV
•- Known participation in other interventional trials
•- Known former participation in this trial

发起方

niversität Leipzig