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

NCT07443241 | Completed

• 1 other identifier: 24-161RS
• Study Type: observational
• Target: 779
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Status Epilepticus

Keywords

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

Outcome Measures

Primary Outcomes (29)

• Age at SE Onset

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

  Baseline (day 1)

• Diagnosis of SE Subtype

  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, %)

  During hospital stay, maximum 30 days

• Semiology: Focal vs. Generalized

  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, %)

  During hospital stay, maximum 30 days

• Non-convulsive SE

  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, %)

  During hospital stay, maximum 30 days

• History of Epilepsy Prior to SE

  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, %)

  Baseline (day 1)

• Guideline-based Treatment of SE

  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, %)

  During hospital stay, maximum 30 days

• Intubation During Treatment of SE

  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, %)

  During hospital stay, maximum 30 days

• History of Epilepsy Surgery

  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, %)

  Baseline (day 1)

• Length of Hospital Stay

  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)

  Up to 100 days

• Availability of Brain MRI During Hospital Stay

  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, %)

  During hospital stay, maximum 30 days

• Time to Brain MRI After SE Onset

  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)

  During hospital stay, maximum 30 days

• EEG with SE Available

  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, %)

  During hospital stay, maximum 30 days

• EEG Control Available

  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, %)

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

• Functional Outcome at Discharge (mRS)

  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)

  Through study completion, an average of 12 days

• Discharge Destination

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

  Through study completion, an average of 12 days

• Survival After One Year

  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, %)

  One year after SE onset

• Total Costs of Hospital Stay

  Total costs of hospitalization for SE as documented in hospital billing records. Unit of measure: Euro (mean, SD)

  Through study completion, an average of 12 days

• Antiseizure Medication (ASM) Use Prior to SE

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

  Baseline (day 1)

• Number of Distinct ASMs Prior to SE

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

  Baseline (day 1)

• Type of ASMs Used Prior to SE

  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

  Baseline (day 1)

• Prehospital Benzodiazepine Use Before SE

  Documentation of whether a benzodiazepine was administered prior to hospital admission for SE. Categories: yes; no Unit of measure: n, %

  Baseline (day 1)

• Number of Distinct Prehospital Benzodiazepines

  Number of different benzodiazepines administered per patient prior to hospital admission for SE. Unit of measure: mean (SD)

  Baseline (day 1)

• Type of Prehospital Benzodiazepines Used

  Specific benzodiazepines administered prior to hospital admission for SE, including clonazepam, diazepam, lorazepam, midazolam. Unit of measure: n, % for each substance

  Baseline (day 1)

• ASM Use During SE Treatment

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

  During hospital stay, maximum 30 days

• Number of Distinct ASMs During SE

  Number of different ASMs administered per patient during hospitalization for SE. Unit of measure: mean (SD)

  During hospital stay, maximum 30 days

• Type of ASMs Used During SE

  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

  During hospital stay, maximum 30 days

• In-hospital Benzodiazepine Use

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

  During hospital stay, maximum 30 days

• Number of Distinct In-hospital Benzodiazepines

  Number of different benzodiazepines administered per patient during hospitalization for SE. Unit of measure: mean (SD)

  During hospital stay, maximum 30 days

• Type of In-hospital Benzodiazepines Used

  Specific benzodiazepines administered during hospitalization for SE, including lorazepam, diazepam, midazolam, clonazepam, clobazam. Unit of measure: n, % for each substance

  During hospital stay, maximum 30 days

Study Arms (2)

Female patients

Female patients diagnosed with Status epilepticus (SE) and treated at Marburg University Hospital between 2011 and 2023. All patients were identified retrospectively. Data were analyzed to assess differences in etiology, diagnostics, treatment, and outcomes compared to male patients. No study-specific intervention was applied.

Male patients

Male patients diagnosed with SE and treated at Marburg University Hospital between 2011 and 2023. All patients were identified retrospectively. Data were analyzed to assess differences in etiology, diagnostics, treatment, and outcomes compared to female patients. No study-specific intervention was applied.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective cohort of 779 adult patients diagnosed with status epilepticus (SE) and treated at Marburg University Hospital (Germany) between 2011 and 2023. Patients of all sexes were included. Data were extracted from electronic medical records and included demographics, clinical presentation, diagnostics, treatment, and outcomes.

You may qualify if:

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

You may not qualify if:

• children

Sponsors & Collaborators

• University Hospital Marburg: lead

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Consultant in Neurology

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: March 2, 2026
• Study Start: December 16, 2010
• Primary Completion: March 27, 2024
• Study Completion: March 27, 2024
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share