Status Epilepticus in Men and Women: Clinical Presentation, Management, and Outcomes

Primary outcomes

1. Age at SE Onset

   Time frame: Baseline (day 1)

   Age in years at the time of SE onset as documented in the medical record.

2. Diagnosis of SE Subtype

   Time frame: During hospital stay, maximum 30 days

   Classification of SE subtype based on clinical presentation and EEG findings, documented in the medical record. Categories include absence SE, generalized tonic-clonic SE, SE with complex focal seizure.

   Aggregation method / Unit of measure: Number and percentage of participants (n, %)

3. Semiology: Focal vs. Generalized

   Time frame: During hospital stay, maximum 30 days

   Seizure semiology classified as focal or generalized based on clinical presentation and EEG documentation in the medical record Categories: focal; generalized Aggregation method / Unit of measure: Number and percentage of participants (n, %)

4. Non-convulsive SE

   Time frame: During hospital stay, maximum 30 days

   Occurrence of non-convulsive SE, classified according to clinical and EEG findings as documented in the medical record.

   Categories: convulsive; non-convulsive Aggregation method / Unit of measure: Number and percentage of participants (n, %)

5. History of Epilepsy Prior to SE

   Time frame: Baseline (day 1)

   Presence or absence of a previously established epilepsy diagnosis, as documented in the medical record before the index SE event.

   Categories: yes / no Aggregation method / Unit of measure: Number and percentage of participants (n, %)

6. Guideline-based Treatment of SE

   Time frame: During hospital stay, maximum 30 days

   Adherence to evidence-based guideline recommendations for the stepwise treatment of SE. Guideline adherence will be evaluated according to the following treatment algorithm (Rosenow and Weber, 2000): 1. Initial treatment with sufficient doses of intravenous lorazepam, intramuscular or intranasal midazolam, or intravenous diazepam. 2. Escalation to intravenous valproic acid or levetiracetam, and if needed, phenytoin or lacosamide. 3. For refractory SE, intensive care unit (ICU) admission with intubation and administration of intravenous anesthetics (propofol, midazolam, or thiopental).

   Categories: treatment according to guidelines; treatment not according to guidelines Aggregation method / Unit of measure: Number and percentage of participants (n, %)

7. Intubation During Treatment of SE

   Time frame: During hospital stay, maximum 30 days

   Requirement for endotracheal intubation as part of the management of SE, documented in the medical record. Intubation was typically performed in the context of refractory SE and/or administration of intravenous anesthetics.

   Categories: intubated; not intubated Aggregation method / Unit of measure: Number and percentage of participants (n, %)

8. History of Epilepsy Surgery

   Time frame: Baseline (day 1)

   Documentation of whether the patient had undergone epilepsy surgery prior to the index SE event, as recorded in the medical history.

   Categories: previous epilepsy surgery; no previous epilepsy surgery Aggregation method / Unit of measure: Number and percentage of participants (n, %)

9. Length of Hospital Stay

   Time frame: Up to 100 days

   Duration of hospitalization in days for the index admission due to SE, documented in the medical record. Data will be summarized as mean and standard deviation (SD).

   Unit of measure: Days (mean, SD)

10. Availability of Brain MRI During Hospital Stay

    Time frame: During hospital stay, maximum 30 days

    Documentation of whether a brain MRI was performed and available for diagnostic evaluation during hospitalization for SE.

    Categories: MRI available; MRI not available Aggregation method / Unit of measure: Number and percentage of participants (n, %)

11. Time to Brain MRI After SE Onset

    Time frame: During hospital stay, maximum 30 days

    Number of days between the onset of SE and the performance of a brain MRI, as documented in the medical record.

    Unit of measure: Days (mean, SD)

12. EEG with SE Available

    Time frame: During hospital stay, maximum 30 days

    Documentation of whether an EEG demonstrating SE was performed and available during hospitalization.

    Categories: EEG available; EEG not available Aggregation method / Unit of measure: Number and percentage of participants (n, %)

13. EEG Control Available

    Time frame: From hospital stay through follow-up (up to study completion, an average of 1 year)

    Documentation of whether a follow-up EEG (control EEG) was performed after the initial EEG confirming SE, as recorded in the medical record.

    Categories: EEG control available; EEG control not available Aggregation method / Unit of measure: Number and percentage of participants (n, %)

14. Functional Outcome at Discharge (mRS)

    Time frame: Through study completion, an average of 12 days

    Functional status at hospital discharge measured by the modified Rankin Scale (mRS) (mRS, range 0-6, where 0 = no symptoms and 6 = death).

    Unit of measure: mRS score (mean, SD)

15. Discharge Destination

    Time frame: Through study completion, an average of 12 days

    Place of discharge following hospitalization for SE. Categories: home; rehabilitation; another clinic; deceased Aggregation method / Unit of measure: Number and percentage of participants (n, %)

16. Survival After One Year

    Time frame: One year after SE onset

    Vital status one year after the index SE event, ascertained from medical records.

    Categories: alive; deceased Aggregation method / Unit of measure: Number and percentage of participants (n, %)

17. Total Costs of Hospital Stay

    Time frame: Through study completion, an average of 12 days

    Total costs of hospitalization for SE as documented in hospital billing records.

    Unit of measure: Euro (mean, SD)

18. Antiseizure Medication (ASM) Use Prior to SE

    Time frame: Baseline (day 1)

    Documentation of chronic ASM treatment prior to the index SE. Categories: yes; no Unit of measure: n, %

19. Number of Distinct ASMs Prior to SE

    Time frame: Baseline (day 1)

    Number of different ASMs prescribed per patient prior to the index SE. Unit of measure: mean (SD)

20. Type of ASMs Used Prior to SE

    Time frame: Baseline (day 1)

    Specific ASMs used prior to SE, including brivaracetam, carbamazepine, clobazam, clonazepam, diazepam, eslicarbazepine, ethosuximide, gabapentin, lacosamide, levetiracetam, lamotrigine, lorazepam, midazolam, oxcarbazepine, perampanel, phenobarbital, phenytoin, primidone, retigabine, rufinamide, stiripentol, topiramate, valproate, vigabatrin, zonisamide.

    Unit of measure: n, % for each substance

21. Prehospital Benzodiazepine Use Before SE

    Time frame: Baseline (day 1)

    Documentation of whether a benzodiazepine was administered prior to hospital admission for SE.

    Categories: yes; no Unit of measure: n, %

22. Number of Distinct Prehospital Benzodiazepines

    Time frame: Baseline (day 1)

    Number of different benzodiazepines administered per patient prior to hospital admission for SE.

    Unit of measure: mean (SD)

23. Type of Prehospital Benzodiazepines Used

    Time frame: Baseline (day 1)

    Specific benzodiazepines administered prior to hospital admission for SE, including clonazepam, diazepam, lorazepam, midazolam.

    Unit of measure: n, % for each substance

24. ASM Use During SE Treatment

    Time frame: During hospital stay, maximum 30 days

    Documentation of whether an ASM was administered during hospitalization for SE. Categories: yes; no Unit of measure: n, %

25. Number of Distinct ASMs During SE

    Time frame: During hospital stay, maximum 30 days

    Number of different ASMs administered per patient during hospitalization for SE.

    Unit of measure: mean (SD)

26. Type of ASMs Used During SE

    Time frame: During hospital stay, maximum 30 days

    Specific ASMs administered during hospitalization for SE, including brivaracetam, carbamazepine, clobazam, clonazepam, eslicarbazepine, gabapentin, lacosamide, levetiracetam, lamotrigine, lorazepam, oxcarbazepine, perampanel, phenobarbital, phenytoin, primidone, retigabine, rufinamide, stiripentol, topiramate, valproate, vigabatrin, zonisamide.

    Unit of measure: n, % for each substance

27. In-hospital Benzodiazepine Use

    Time frame: During hospital stay, maximum 30 days

    Documentation of whether a benzodiazepine was administered during hospitalization for SE.

    Categories: yes; no Unit of measure: n, %

28. Number of Distinct In-hospital Benzodiazepines

    Time frame: During hospital stay, maximum 30 days

    Number of different benzodiazepines administered per patient during hospitalization for SE.

    Unit of measure: mean (SD)

29. Type of In-hospital Benzodiazepines Used

    Time frame: During hospital stay, maximum 30 days

    Specific benzodiazepines administered during hospitalization for SE, including lorazepam, diazepam, midazolam, clonazepam, clobazam.

    Unit of measure: n, % for each substance