Health TrialsbyHealthPanel

Status Epilepticus in the Critically Ill Patients

ConditionStatus Epilepticus
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIctal Group

About this trial

Convulsive and Non Convulsive Status Epilepticus (SE) and Pseudo Status Epilepticus prospective registry.

Data collection using a standardized form : demographic data and data related to the SE, including circumstances of onset, dates and times of onset and of seizure control, on-scene clinical findings, clinical features of the seizures, pre-hospital and hospital care providers, timing of antiepileptic and supportive treatments, results of etiological investigations, cause of SE, type and dosage of antiepileptic drugs. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

SE defined as 5 min or more of (i) continuous clinical and/or electrographic seizure activity or (ii) recurrent seizure activity without recovery (returning to baseline) between seizures.

age >= 18 years

Disqualifiers

age < 18 years

postanoxic status epilepticus

Trial population

critically ill patients requiring ICU hospitalisation

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 1 trial group
Group A: Status Epilepticus

Trial outcomes

Primary outcomes

1

Favorable outcome

A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined according to patients charts review and/or general practitioner interview conducted by an independent assessor. The GOS score : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

Time frame
1 year

Secondary outcomes

1

Favorable outcome

A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined patients charts review and/or general practitioner interview conducted by an independent assessor. The GOS score : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

Time frame
3 months, 5-years and 10 years
2

Functional impairment

Percentages of the patients that experience functional impairment (motor, sensitive, cognitive, epilepsy)

Time frame
3 months, and 1-year, 5-years and 10-years
3

total seizure duration

total seizure duration in minutes

Time frame
72 hours
4

percentages of the patients that experience recurrent convulsive and/or non-convulsive seizures within 12 hours after ICU admission

Time frame
12 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ictal Group

Lead sponsor

Versailles Hospital

Collaborator

Source ClinicalTrials.gov
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