Status:
COMPLETED
Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Status Epilepticus
Epilepsy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to know on one hand if lorazepam is more (effective) than clonazepam and on the other hand if lorazepam is also effective as the association clonazepam + fosphenytoin...
Detailed Description
Background: Early and rapid termination of status epilepticus with intravenous administration of benzodiazepines only or its association with other antiepileptic drug improves outcomes. Our out-of-hos...
Eligibility Criteria
Inclusion
- Patients aged 18 years or older
- Out-of-hospital management
- presenting one of the criteria below noticed by the physician of the mobile intensive care unit:
- convulsive seizures at the time of treatment and were reported by reliable witnesses to have been continuously convulsing for longer than 5 minutes, without regaining consciousness, or
- if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness
Exclusion
- Patient having been already included in the study during a previous episode of status epilepticus
- Patient having already received before the arrival of the mobile intensive care unit one of theses studied drugs (lorazepam, clonazepam or fosphenytoin or phenytoin)
- Latent status epilepticus in deep coma
- Cerebral anoxia (post cardio respiratory arrest)
- Severe head trauma
- Patient presenting convulsive seizures of psychogenic origin
- Lennox Gastaut's syndrome
- Decision of urgent intubation
- Patients of more than 110 kg ( estimated weight
- Heart rate \< 60 bpm or \> 150 bpm
- Systolic Blood Pressure \< 90 mmHg
- Atrioventricular block of 2nd or 3rd degree
- Ventricular tachycardia or ventricular fibrillation
- Sensibility known about benzodiazepines, fosphenytoin, phenytoin, other hydantoins, or barbiturate
- Contraindication known about benzodiazepines (severe respiratory failure, severe acute hepatic failure, myasthenia, syndrome of sleep apnea, glaucoma with closed angle
- Contraindication known about fosphenytoin (intermittent acute porphyry)
- Contraindication known about barbiturate (porphyry, severe respiratory failure, current treatment by saquinavir, ifosfamide and voriconazole, in association with millepertuis)
- Person unaffiliated in a National Social Security Insurance
- Pregnant or breast-feeding Woman
- Impossibility to put an intravenous or intra-osseous catheter for the treatment injection
- Absence of nurse in the mobile intensive care unit.
Key Trial Info
Start Date :
June 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2018
Estimated Enrollment :
434 Patients enrolled
Trial Details
Trial ID
NCT01870024
Start Date
June 26 2013
End Date
February 23 2018
Last Update
October 11 2018
Active Locations (1)
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1
Département d'Anesthésie - Réanimation - SMUR - Hôpital Lariboisière
Paris, France, 75010