Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasme University Hospital

About this trial

SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or above

Patients admitted for management of Status Epilepticus as their primary diagnosis

Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay

Disqualifiers

None

Trial population

All patients of and above 18 years admitted for Status Epilepticus management or who develop Status Epilepticus during their hospital stay

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Modified Rankin Scale

Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).

Time frame
On the date of discharge from hospital or date of death from any cause, assessed up to 24 months
2

Refractoriness

Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.

Time frame
From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months

Secondary outcomes

1

Modified Rankin Scale

Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).

Time frame
At 30 days after the date of inclusion or SE onset (if still hospitalized)
2

Modified Rankin Scale

Functional outcome will be assessed by the modified Rankin scale (mRS). mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).

Time frame
At 3 months after the date of discharge from hospital
3

Super-refractoriness

Super-refractory status epilepticus is defined as Status Epilepticus persisting or recurring after 24 hours or more of treatment with continuous intravenous anesthetic drugs or when therapy is tapered after 24 hours of use.

Time frame
From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months

Other outcomes

Sponsors and contacts

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