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临床试验/NCT07443241
NCT07443241已完成不适用

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

University Hospital Marburg0 个研究点目标入组 779 人开始时间: 2010年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
779
主要终点
Age at SE Onset

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

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.

结局指标

主要结局

Age at SE Onset

时间窗: Baseline (day 1)

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

Diagnosis of SE Subtype

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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, %)

Time to Brain MRI After SE Onset

时间窗: 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)

Guideline-based Treatment of SE

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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, %)

EEG with SE Available

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Baseline (day 1)

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

Number of Distinct ASMs During SE

时间窗: 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 Prior to SE

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: During hospital stay, maximum 30 days

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

Type of ASMs Used During SE

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
University Hospital Marburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leona Möller

Principal Investigator, Consultant in Neurology

University Hospital Marburg

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