Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-24 @ 9:54 PM
NCT ID:
NCT01359332
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01359332
Study Brief:
Protocol Section:
NCT01359332