Status EpilepticusNCT00318578
Prognosis Factors Associated With Convulsive Status Epilepticus in Adults
An observational study of Status Epilepticus, run by Versailles Hospital at 34 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus
- How many people
- 100 participants
- Where
- 34 sitesFrance
- Study dates
- Mar 2005to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 18 years old
- Patients that seized up to 9 minutes
- Beginning of seizure more than 12 hours before intensive care unit admission
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
France34 sites
Centre Hospitalier d'Abbeville
Abbeville, 80100
Centre Hospitalier d'Annonay
Annonay, 07103
Centre Hospitalier Victor Dupouy
Argenteuil, 95100
Centre Hospitalier Robert Ballanger
Aulnay-sous-Bois, 93
Centre Hospitalier Rene Dubos
Cergy-Pontoise, 95303
Centre Hospitalier de Châlons-en-Champagne
Châlons-en-Champagne, 51000
Centre Hospitalier de Chartres
Chartres, 28
Centre Hospitalier Universitaire Antoine Beclere
Clamart, 92140
Hopital Gabriel Montpied
Clermont-Ferrand, 63000
Centre Hospitalier de Compiegne
Compiègne, 60200
Centre Hospitalier Universitaire Henri Mondor
Créteil, 94000
Centre Hospitalier de Dourdan
Dourdan, 91410
Centre Hospitalier de Dreux
Dreux, 28102
Centre Hospitalier Universitaire de Grenoble
Grenoble, 38
Centre Hospitalier de Versailles
Le Chesnay, 78150
Centre Hospitalier Universitaire La Timone
Marseille, 13385
Centre Hospitalier Sambre Avesnois
Maubeuge, 59607
Centre Hospitalier de Meaux
Meaux, 77107
Centre Hospitalier Universitaire de Nancy
Nancy, 54035
Centre Hospitalier Pierre Bérégovoy
Nevers, 58000
Centre Hôspitalier ARCHET
Nice, 06202
Centre Hospitalier Georges Renon
Niort, 79021
Centre Hospitalier Universitaire d'Orléans
Orléans, 45067
Centre Hospitalier Universitaire Cochin
Paris, 75000
Centre Hospitalier Universitaire Lariboisiere
Paris, 75000
Centre Hospitalier Bichat Claude Bernard
Paris, 75
Fondation Hopital Saint Joseph
Paris, 75
Centre Hospitalier Francois Mitterrand
Pau, 64046
Clinique Mutualiste de Pessas
Pessac, 33600
Centre Hospitalier Universitaire de Poitiers
Poitiers
Centre Hospitalier de Roanne
Roanne, 42328
Centre Hospitalier de Rodez
Rodez, 12
Centre Hospitalier Mémorail France Etats Unis Saint Lo
Saint-Lô, 50000
Centre Hospitalier Foch
Suresnes, 92151
About this study
Official title: Prognosis Factors Associated With Convulsive Status Epilepticus in Adults: A Multicenter Cohort Study
The aim of the study is to evaluate, prospectively, prognosis factors associated with convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.
Read the 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.
- Conditions
- Status Epilepticus
- Keywords
- convulsive status epilepticus, outcome, prognosis factors, seizure duration, adult, electroencephalogram, intensive care unit
- Medical subject headings
- Status Epilepticus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startMar 2005
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Stephane LEGRIEL, MD, Principal investigator, Versailles HospitalBruno MOURVILLIER, MD, Principal investigator, Centre Hospitalier Bichat Claude Bernard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318578
- Sponsor's protocol ID
- LEGRIEL stephane
- Status last verified
- Aug 2007
- First submitted
- 25 Apr 2006
- Last updated
- 15 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Factors Associated With Convulsive Status Epilepticus in Adults: A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT00318578
- Acronym / sponsor ID
- LEGRIEL stephane
- Conditions
- Status Epilepticus
- Keywords
- convulsive status epilepticus, outcome, prognosis factors, seizure duration, adult, electroencephalogram, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Mar 2005
- Study completion
- Jan 2007
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to evaluate, prospectively, prognosis factors associated with convulsive status epilepticus (CSE) in adults hospitalized in intensive care units.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Less than 18 years old
- Patients that seized up to 9 minutes
- Beginning of seizure more than 12 hours before intensive care unit admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephane LEGRIEL, MD principal investigator
Versailles Hospital
Bruno MOURVILLIER, MD principal investigator
Centre Hospitalier Bichat Claude Bernard
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus, run by Versailles Hospital at 34 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2007.