Skip to content

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

Gender-specific Differences in the Etiology, Diagnosis, Treatment and Outcome of Status Epilepticus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07443241
Enrollment
779
Registered
2026-03-02
Start date
2010-12-16
Completion date
2024-03-27
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status Epilepticus

Keywords

Status epilepticus, Gender differences in neurology, Gender differences in Status epilepticus, Antiseizure medication

Brief summary

Sex-specific differences in neurological emergencies such as Status epilepticus (SE) remain understudied despite growing recognition of gender disparities in medicine. This study aimes to investigate sex-related differences in etiology, diagnostics, treatment, and outcomes among patients with SE. The investigators conducted a retrospective analysis of 779 patients treated with SE at Marburg University Hospital between 2011 and 2023.

Interventions

None listed

Sponsors

University Hospital Marburg
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* patients who were treated at Marburg University Hospital (UKGM Marburg) between January 2011 to March 2023 with diagnosis of SE

Exclusion criteria

* children

Design outcomes

Primary

MeasureTime frameDescription
Age at SE OnsetBaseline (day 1)Age in years at the time of SE onset as documented in the medical record.
Diagnosis of SE SubtypeDuring hospital stay, maximum 30 daysClassification 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, %)
Semiology: Focal vs. GeneralizedDuring hospital stay, maximum 30 daysSeizure 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, %)
Non-convulsive SEDuring hospital stay, maximum 30 daysOccurrence 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, %)
History of Epilepsy Prior to SEBaseline (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, %)
Guideline-based Treatment of SEDuring hospital stay, maximum 30 daysAdherence 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, %)
Intubation During Treatment of SEDuring hospital stay, maximum 30 daysRequirement 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, %)
History of Epilepsy SurgeryBaseline (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, %)
Length of Hospital StayUp to 100 daysDuration 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)
Availability of Brain MRI During Hospital StayDuring hospital stay, maximum 30 daysDocumentation 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, %)
Time to Brain MRI After SE OnsetDuring hospital stay, maximum 30 daysNumber 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)
EEG with SE AvailableDuring hospital stay, maximum 30 daysDocumentation 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, %)
EEG Control AvailableFrom 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, %)
Functional Outcome at Discharge (mRS)Through study completion, an average of 12 daysFunctional 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)
Discharge DestinationThrough study completion, an average of 12 daysPlace of discharge following hospitalization for SE. Categories: home; rehabilitation; another clinic; deceased Aggregation method / Unit of measure: Number and percentage of participants (n, %)
Survival After One YearOne year after SE onsetVital 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, %)
Total Costs of Hospital StayThrough study completion, an average of 12 daysTotal costs of hospitalization for SE as documented in hospital billing records. Unit of measure: Euro (mean, SD)
Antiseizure Medication (ASM) Use Prior to SEBaseline (day 1)Documentation of chronic ASM treatment prior to the index SE. Categories: yes; no Unit of measure: n, %
Number of Distinct ASMs Prior to SEBaseline (day 1)Number of different ASMs prescribed per patient prior to the index SE. Unit of measure: mean (SD)
Type of ASMs Used Prior to SEBaseline (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
Prehospital Benzodiazepine Use Before SEBaseline (day 1)Documentation of whether a benzodiazepine was administered prior to hospital admission for SE. Categories: yes; no Unit of measure: n, %
Number of Distinct Prehospital BenzodiazepinesBaseline (day 1)Number of different benzodiazepines administered per patient prior to hospital admission for SE. Unit of measure: mean (SD)
Type of Prehospital Benzodiazepines UsedBaseline (day 1)Specific benzodiazepines administered prior to hospital admission for SE, including clonazepam, diazepam, lorazepam, midazolam. Unit of measure: n, % for each substance
ASM Use During SE TreatmentDuring hospital stay, maximum 30 daysDocumentation of whether an ASM was administered during hospitalization for SE. Categories: yes; no Unit of measure: n, %
Number of Distinct ASMs During SEDuring hospital stay, maximum 30 daysNumber of different ASMs administered per patient during hospitalization for SE. Unit of measure: mean (SD)
Type of ASMs Used During SEDuring hospital stay, maximum 30 daysSpecific 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
In-hospital Benzodiazepine UseDuring hospital stay, maximum 30 daysDocumentation of whether a benzodiazepine was administered during hospitalization for SE. Categories: yes; no Unit of measure: n, %
Number of Distinct In-hospital BenzodiazepinesDuring hospital stay, maximum 30 daysNumber of different benzodiazepines administered per patient during hospitalization for SE. Unit of measure: mean (SD)
Type of In-hospital Benzodiazepines UsedDuring hospital stay, maximum 30 daysSpecific benzodiazepines administered during hospitalization for SE, including lorazepam, diazepam, midazolam, clonazepam, clobazam. Unit of measure: n, % for each substance

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026