Recruitment

Recruitment Status
Completed
Estimated Enrollment
522

Inclusion Criterias

Out-of-hospital management
if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness
Patients aged 18 years or older
...
Out-of-hospital management
if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness
Patients aged 18 years or older
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

Exclusion Criterias

Ventricular tachycardia or ventricular fibrillation
Atrioventricular block of 2nd or 3rd degree
Absence of nurse in the mobile intensive care unit.
...
Ventricular tachycardia or ventricular fibrillation
Atrioventricular block of 2nd or 3rd degree
Absence of nurse in the mobile intensive care unit.
Cerebral anoxia (post cardio respiratory arrest)
Latent status epilepticus in deep coma
Patient having already received before the arrival of the mobile intensive care unit one of theses studied drugs (lorazepam, clonazepam or fosphenytoin or phenytoin)
Contraindication known about fosphenytoin (intermittent acute porphyry)
Heart rate < 60 bpm or > 150 bpm
Pregnant or breast-feeding Woman
Sensibility known about benzodiazepines, fosphenytoin, phenytoin, other hydantoins, or barbiturate
Lennox Gastaut's syndrome
Impossibility to put an intravenous or intra-osseous catheter for the treatment injection
Person unaffiliated in a National Social Security Insurance
Systolic Blood Pressure < 90 mmHg
Contraindication known about benzodiazepines (severe respiratory failure, severe acute hepatic failure, myasthenia, syndrome of sleep apnea, glaucoma with closed angle
Decision of urgent intubation
Patient having been already included in the study during a previous episode of status epilepticus
Patients of more than 110 kg ( estimated weight
Contraindication known about barbiturate (porphyry, severe respiratory failure, current treatment by saquinavir, ifosfamide and voriconazole, in association with millepertuis)
Severe head trauma
Patient presenting convulsive seizures of psychogenic origin

Summary

Conditions
  • Epilepsy
  • Status Epilepticus
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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-hospital study aims to demonstrate on one hand the superiority of lorazepam compared with clonazepam an...

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-hospital study aims to demonstrate on one hand the superiority of lorazepam compared with clonazepam and on the other hand the efficacy at least equivalent of lorazepam in comparison with the association clonazepam + fosphenytoin. If these hypotheses are demonstrated, the out-of-hospital treatment of the status epilepticus by lorazepam in monotherapy would then be strongly recommended, considering its efficacy and the simplicity of administration in the context of the pre-hospital emergency.Objective: To compare the efficacy of Lorazepam with that of Clonazepam and its association with Fosphenytoin for the treatment of out-of-hospital status epilepticus. Participating centers: 41 prehospital emergency services employing mobile intensive care units and located in urban areas in France participated in this study. In France, the management of out-of-hospital medical emergencies is under the responsibility of the Service d'Aide Medicale Urgente (SAMU). Mobile intensive care units are staffed by an attending emergency physician or anesthesiologist, a nurse, and an ambulance driver. The study is coordinated by the prehospital emergency service of Lariboisiere Hospital, University Paris 7 (Paris, France) Number of patients: 522 patients; 174 patients by group. Duration of the study: The total duration planned is of 48 months Intermediate analysis: An intermediate analysis is planned while 261 patients will be included (50 % of the inclusions).Duration of participation of every patient: 24 hours Data collection: prehospital data recording during the 60 min period of the study, and intrahospital data recording by the medical report of hospitalization. Methodology: Multicenter, randomized, double-blind trial with 3 arms. Main criteria of evaluation: the cessation of the status epilepticus and the absence of recurrence from T20 minutes until T60 minutes after the beginning of the treatment. The cessation of the status epilepticus is defined by the stop of any motor activity and any seizures or convulsive movements. The absence of recurrence is defined by the not occurrence of a new seizures after a period of cessation.

Inclusion Criterias

Out-of-hospital management
if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness
Patients aged 18 years or older
...
Out-of-hospital management
if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness
Patients aged 18 years or older
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

Exclusion Criterias

Ventricular tachycardia or ventricular fibrillation
Atrioventricular block of 2nd or 3rd degree
Absence of nurse in the mobile intensive care unit.
...
Ventricular tachycardia or ventricular fibrillation
Atrioventricular block of 2nd or 3rd degree
Absence of nurse in the mobile intensive care unit.
Cerebral anoxia (post cardio respiratory arrest)
Latent status epilepticus in deep coma
Patient having already received before the arrival of the mobile intensive care unit one of theses studied drugs (lorazepam, clonazepam or fosphenytoin or phenytoin)
Contraindication known about fosphenytoin (intermittent acute porphyry)
Heart rate < 60 bpm or > 150 bpm
Pregnant or breast-feeding Woman
Sensibility known about benzodiazepines, fosphenytoin, phenytoin, other hydantoins, or barbiturate
Lennox Gastaut's syndrome
Impossibility to put an intravenous or intra-osseous catheter for the treatment injection
Person unaffiliated in a National Social Security Insurance
Systolic Blood Pressure < 90 mmHg
Contraindication known about benzodiazepines (severe respiratory failure, severe acute hepatic failure, myasthenia, syndrome of sleep apnea, glaucoma with closed angle
Decision of urgent intubation
Patient having been already included in the study during a previous episode of status epilepticus
Patients of more than 110 kg ( estimated weight
Contraindication known about barbiturate (porphyry, severe respiratory failure, current treatment by saquinavir, ifosfamide and voriconazole, in association with millepertuis)
Severe head trauma
Patient presenting convulsive seizures of psychogenic origin

Locations

Paris, 75010
Paris, 75010

Tracking Information

NCT #
NCT01870024
Collaborators
Not Provided
Investigators
  • Principal Investigator: Papa GUEYE, MD, PhD Assistance Publique - Hôpitaux de Paris Principal Investigator: François CONCINA, MD CHU Toulouse - Hôpital Purpan
  • Papa GUEYE, MD, PhD Assistance Publique - Hôpitaux de Paris Principal Investigator: François CONCINA, MD CHU Toulouse - Hôpital Purpan