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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 132

Inclusion Criteria

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.)

Exclusion Criteria

- 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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is the effectiveness of intravenous valproate or levetiracetam to terminate established status epilepticus and maintain control of epileptic activity up to 60 minutes after initiation of the trial intervention.

Secondary Outcome Measures