LORACLOFTComparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus in Adults Patients
Clonazepam
+ Placebo
+ Fosphenytoin
Brain Diseases+6
+ Central Nervous System Diseases
+ Epilepsy
Treatment Study
Summary
Study start date: June 26, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.434 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * 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: 1. 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 2. if they were having more than 2 repeated convulsive seizures at the time of treatment without regaining consciousness Exclusion Criteria: * 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Département d'Anesthésie - Réanimation - SMUR - Hôpital Lariboisière
Paris, FranceOpen Département d'Anesthésie - Réanimation - SMUR - Hôpital Lariboisière in Google Maps