Status EpilepticusNCT07443241
Status Epilepticus in Men and Women: Clinical Presentation, Management, and Outcomes
An observational study of Status Epilepticus, run by University Hospital Marburg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus
- How many people
- 779 participants
- Where
- No sites listed yet
- Study dates
- 16 Dec 2010to 27 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients who were treated at Marburg University Hospital (UKGM Marburg) between January 2011 to March 2023 with diagnosis of SE
Who cannot join
- children
About this study
Official title: Gender-specific Differences in the Etiology, Diagnosis, Treatment and Outcome of Status Epilepticus
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
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age at SE Onset
Age in years at the time of SE onset as documented in the medical record.
Measured: 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, %)
Measured: 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, %)
Measured: 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, %)
Measured: 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, %)
Measured: 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, %)
Measured: 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, %)
Measured: 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, %)
Measured: 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)
Measured: 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, %)
Measured: 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)
Measured: 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, %)
Measured: 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, %)
Measured: 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)
Measured: 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, %)
Measured: 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, %)
Measured: 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)
Measured: 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, %
Measured: 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)
Measured: 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
Measured: 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, %
Measured: 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)
Measured: 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
Measured: 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, %
Measured: 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)
Measured: 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
Measured: 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, %
Measured: 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)
Measured: 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
Measured: During hospital stay, maximum 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start16 Dec 2010
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 779 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leona Möller, University Hospital Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443241
- Sponsor's protocol ID
- 24-161RS
- Status last verified
- Mar 2026
- First submitted
- 15 Aug 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gender-specific Differences in the Etiology, Diagnosis, Treatment and Outcome of Status Epilepticus
- ClinicalTrials.gov ID
- NCT07443241
- Acronym / sponsor ID
- 24-161RS
- Conditions
- Status Epilepticus
- Keywords
- Status epilepticus, Gender differences in neurology, Gender differences in Status epilepticus, Antiseizure medication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 779 participants (actual)
- Lead sponsor
- University Hospital MarburgUniversity, hospital or other
- Study start
- 16 Dec 2010 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- patients who were treated at Marburg University Hospital (UKGM Marburg) between January 2011 to March 2023 with diagnosis of SE
Key exclusion criteria (1 listed)
- children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Age at SE Onset
Time frame: Baseline (day 1)
Age in years at the time of SE onset as documented in the medical record.
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, %)
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, %)
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, %)
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, %)
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, %)
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, %)
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, %)
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)
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, %)
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)
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, %)
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, %)
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)
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, %)
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, %)
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)
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, %
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)
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
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, %
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)
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
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, %
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)
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
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, %
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus, run by University Hospital Marburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age at SE Onset (time frame: Baseline (day 1)). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.