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NCT00318578 Clinical Trial

Prognosis Factors Associated With Convulsive Status Epilepticus in Adults

Status Epilepticus Clinical Trial

Official title:
Prognosis Factors Associated With Convulsive Status Epilepticus in Adults: A Multicenter Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00318578
Other study ID # LEGRIEL stephane
Secondary ID
Status Completed
Phase N/A
First received April 25, 2006
Last updated August 13, 2007
Start date March 2005
Est. completion date January 2007

Study information
Verified date August 2007
Source Central Hospital, Versailles
Contact n/a
Is FDA regulated No
Health authority France: CNIL Commission Nationale de l'Informatique et des Libertés
Study type Observational

Clinical Trial Summary

The aim of the study is to evaluate, prospectively, prognosis factors associated with convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.

Description:

Status epilepticus is a neurologic and medical emergency associated with high mortality and morbidity rates. According to the operational definition Convulsive Status Epilepticus (CSE) is defined as a single clinical seizure lasting more than 10 min, or two or more repeated seizures over a period of more than 10 minutes without intervening recovery of consciousness.

There are a few to date in literature reporting prognosis factors associated with this condition and, at this time, there are no published data considering an operational definition of CSE.

In a retrospective study considering an operational definition we identified a seizure duration of 15 min associated with poor outcome (not yet published).

The principal goal of this study is to evaluate factors associated with outcome in CSE, in particular seizure duration of more than 15 minutes.

The secondary goals are to evaluate the epidemiology and management at every stage of CSE thus redefined.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- More than 18 years old

- Convulsive status epilepticus according to operational definition as any seizure lasting for 10 minutes or longer, or two or more intermittent seizures lasting for greater than 10 minutes from which the patient did not regain consciousness.

- Beginning of seizure less than 12 hours before intensive care unit admission

- Convulsive status epilepticus occurring during intensive care unit stay

Exclusion Criteria:

- Less than 18 years old

- Patients that seized up to 9 minutes

- Beginning of seizure more than 12 hours before intensive care unit admission

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
France Centre Hospitalier d'Abbeville Abbeville
France Centre Hospitalier d'Annonay Annonay
France Centre Hospitalier Victor Dupouy Argenteuil
France Centre Hospitalier Robert Ballanger Aulnay Sous Bois
France Centre Hospitalier Rene Dubos Cergy Pontoise
France Centre Hospitalier de Châlons-en-Champagne Châlons-en-Champagne
France Centre Hospitalier de Chartres Chartres
France Centre Hospitalier Universitaire Antoine Beclere Clamart
France Hopital Gabriel Montpied Clermont Ferrand
France Centre Hospitalier de Compiegne Compiegne
France Centre Hospitalier Universitaire Henri Mondor Creteil
France Centre Hospitalier de Dourdan Dourdan
France Centre Hospitalier de Dreux Dreux
France Centre Hospitalier Universitaire de Grenoble Grenoble
France Centre Hospitalier de Versailles Le Chesnay
France Centre Hospitalier Universitaire La Timone Marseille
France Centre Hospitalier Sambre Avesnois Maubeuge
France Centre Hospitalier de Meaux Meaux
France Centre Hospitalier Universitaire de Nancy Nancy
France Centre Hospitalier Pierre Bérégovoy Nevers
France Centre Hôspitalier ARCHET Nice
France Centre Hospitalier Georges Renon Niort
France Centre Hospitalier Universitaire d'Orléans Orleans
France Centre Hospitalier Bichat Claude Bernard Paris
France Centre Hospitalier Universitaire Cochin Paris
France Centre Hospitalier Universitaire Lariboisiere Paris
France Fondation Hopital Saint Joseph Paris
France Centre Hospitalier Francois Mitterrand PAU
France Clinique Mutualiste de Pessas Pessac
France Centre Hospitalier Universitaire de Poitiers Poitiers
France Centre Hospitalier de Roanne Roanne
France Centre Hospitalier de Rodez Rodez
France Centre Hospitalier Mémorail France Etats Unis Saint Lo Saint Lo
France Centre Hospitalier Foch Suresnes

Sponsors (1)
Lead Sponsor Collaborator
Central Hospital, Versailles

Country where clinical trial is conducted

France, 

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Terminated NCT00265616 - Treatment of Refractory Status Epilepticus Phase 3
Enrolling by invitation NCT06403150 - The Efficacy and Safety of Levetiracetam Versus Fosphenytoin in Convulsive Status Epilepticus Phase 4
Recruiting NCT05246566 - Assessment of Adults Epidemiological Characteristics of Status Epilepticus in the French West Indies and in French Guiana