DRKS00022308
Recruiting
Phase 4
Treatment of Established Status Epilepticus in the Elderly - a prospective, randomized, double-blind comparative effectiveness trial - ToSEE
niversität Leipzig0 sites132 target enrollmentJuly 3, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- G41.9
- Sponsor
- niversität Leipzig
- Enrollment
- 132
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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