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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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26 November 2012 |
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Main ID: |
NCT01359332 |
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Date of registration:
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23/05/2011 |
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Primary sponsor: |
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Public title:
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Evaluation of Therapeutic Hypothermia in Convulsive Status EPILEPTICUS in Adults in Intensive Care
HYBERNATUS |
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Scientific title:
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Evaluation of the Interests of a Therapeutic Hypothermia Procedure in Convulsive Status EPILEPTICUS in Adults in Intensive Care - HYBERNATUS Study |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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270 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01359332 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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France
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Contacts
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Name:
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Stéphane LEGRIEL, MD |
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Address:
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Telephone:
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33(0)1 39 63 88 39 |
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Email:
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slegriel@ch-versailles.fr |
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Affiliation:
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Name:
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Stéphane LEGRIEL, MD |
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Address:
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Telephone:
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33(1)39638839 |
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Email:
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slegriel@ch-versailles.fr |
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Affiliation:
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Name:
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Stéphane LEGRIEL, MD, |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patient age = 18 years
- patient hospitalized in intensive care unit
- patient already under mechanical ventilation
- patient who presented a convulsive status EPILEPTICUS episode (defined as continuous
SEIZURING for longer than 5 min or three seizures not separated by recovery of normal
consciousness or of the level of consciousness present before the seizures)
- whose motor manifestations had begun less than 8 hours before randomization
- after having informed written consent signed by a parent or a close if present.
Exclusion Criteria:
- patients with full recovery, postanoxic status EPILEPTICUS after cardia arrest
- convulsive status EPILEPTICUS for which an intervention (neurosurgical or other) is
urgently needed not allowing the application of the procedure for therapeutic
hypothermia
- dying patient, limitations in care, or whose life expectancy is estimated at baseline
of less than 1 year
- patients whose follow-up to 3 months (+ / - 1 week) seems a PRIORI not possible
- pregnant women (pregnancy positive urine test or known before inclusion),
- participation in another biomedical therapeutic intervention whose primary endpoint
was not reached at inclusion in HYBERNATUS study
- not affiliation to a social insurance
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Convulsive Status EPILEPTICUS
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Intervention(s)
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Procedure: Moderate hypothermia
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Primary Outcome(s)
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Functional impairment at 3 months
[Time Frame: 3 months]
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Secondary Outcome(s)
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incidence of functional sequelae
[Time Frame: 3 months]
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length of hospital stay
[Time Frame: 3 months]
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length of icu stay
[Time Frame: 3 months]
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mortality
[Time Frame: hospital discharge]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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