Text Size

Prognosis Factors Associated With Convulsive Status Epilepticus in Adults

This study has been completed.
Sponsor:
Information provided by:
Central Hospital, Versailles
ClinicalTrials.gov Identifier:
NCT00318578
First received: April 25, 2006
Last updated: August 13, 2007
Last verified: August 2007
History of Changes
  Purpose

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


Condition
Status Epilepticus

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Prognosis Factors Associated With Convulsive Status Epilepticus in Adults: A Multicenter Cohort Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Central Hospital, Versailles:

Estimated Enrollment: 100
Study Start Date: March 2005
Estimated Study Completion Date: January 2007
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318578

Locations
France
Centre Hospitalier d'Abbeville
Abbeville, France, 80100
Centre Hospitalier d'Annonay
Annonay, France, 07103
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95100
Centre Hospitalier Robert Ballanger
Aulnay Sous Bois, France, 93
Centre Hospitalier Rene Dubos
Cergy Pontoise, France, 95303
Centre Hospitalier de Chartres
Chartres, France, 28
Centre Hospitalier de Châlons-en-Champagne
Châlons-en-Champagne, France, 51000
Centre Hospitalier Universitaire Antoine Beclere
Clamart, France, 92140
Hopital Gabriel Montpied
Clermont Ferrand, France, 63000
Centre Hospitalier de Compiegne
Compiegne, France, 60200
Centre Hospitalier Universitaire Henri Mondor
Creteil, France, 94000
Centre Hospitalier de Dourdan
Dourdan, France, 91410
Centre Hospitalier de Dreux
Dreux, France, 28102
Centre Hospitalier Universitaire de Grenoble
Grenoble, France, 38
Centre Hospitalier de Versailles
Le Chesnay, France, 78150
Centre Hospitalier Universitaire La Timone
Marseille, France, 13385
Centre Hospitalier Sambre Avesnois
Maubeuge, France, 59607
Centre Hospitalier de Meaux
Meaux, France, 77107
Centre Hospitalier Universitaire de Nancy
Nancy, France, 54035
Centre Hospitalier Pierre Bérégovoy
Nevers, France, 58000
Centre Hôspitalier ARCHET
Nice, France, 06202
Centre Hospitalier Georges Renon
Niort, France, 79021
Centre Hospitalier Universitaire d'Orléans
Orleans, France, 45067
Centre Hospitalier Bichat Claude Bernard
Paris, France, 75
Centre Hospitalier Universitaire Lariboisiere
Paris, France, 75000
Centre Hospitalier Universitaire Cochin
Paris, France, 75000
Fondation Hopital Saint Joseph
Paris, France, 75
Centre Hospitalier Francois Mitterrand
PAU, France, 64046
Clinique Mutualiste de Pessas
Pessac, France, 33600
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Centre Hospitalier de Roanne
Roanne, France, 42328
Centre Hospitalier de Rodez
Rodez, France, 12
Centre Hospitalier Mémorail France Etats Unis Saint Lo
Saint Lo, France, 50000
Centre Hospitalier Foch
Suresnes, France, 92151
Sponsors and Collaborators
Central Hospital, Versailles
Investigators
Principal Investigator: Stephane LEGRIEL, MD Centre hospitalier de versailles
Principal Investigator: Bruno MOURVILLIER, MD Centre Hospitalier Bichat Claude Bernard
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00318578     History of Changes
Other Study ID Numbers: LEGRIEL stephane
Study First Received: April 25, 2006
Last Updated: August 13, 2007
Health Authority: France: CNIL Commission Nationale de l'Informatique et des Libertés

Keywords provided by Central Hospital, Versailles:
convulsive status epilepticus
outcome
prognosis factors
seizure duration
 adult
electroencephalogram
intensive care unit

Additional relevant MeSH terms:
Status Epilepticus
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 16, 2013