Status Epilepticus Population Study (STEPS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Demographics
研究概览
简要总结
The aim of this observational multicenter cohort study is to gain a deeper understanding regarding the effects of treatment adaption based on information from outcome prediction models, risk stratification, as well as treatment monitoring, detection, prevention, and management of complications on course and outcome of adult patients with status epilepticus (SE).
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
- 否
入选标准
- •Adult patients (i.e., patients ≥18 years of age) with diagnosed SE between 2005 and 2023 who have been treated at the University Hospital of Basel or the Cantonal Hospital Aarau.
排除标准
- •Patients younger than 18 years.
- •Patients with repetitive epileptic seizures not qualifying for SE.
- •Patients with documented refusal of the general consent.
结局指标
主要结局
Demographics
时间窗: between 01.01.2005 and 31.12.2023
age, sex
Seizure history and etiology
时间窗: between 01.01.2005 and 31.12.2023
withdrawal from anti seizure drugs, structural, infectious, or autoimmune causes
Data from acute prehospital management by the emergency medical services (EMS)
时间窗: between 01.01.2005 and 31.12.2023
extracted from the treatment protocols of the EMS
Duration of ICU (intensive care unit) and hospital stay, and destination at discharge
时间窗: between 01.01.2005 and 31.12.2023
Duration of ICU (intensive care unit) and hospital stay, and destination at discharge
Date(s) of seizure(s) captured by electroencephalographic (EEG) data
时间窗: between 01.01.2005 and 31.12.2023
Date(s) of seizure(s) captured by EEG
Number and Duration of SE episodes
时间窗: between 01.01.2005 and 31.12.2023
Number and Duration (time) of SE episodes
Types of SE
时间窗: between 01.01.2005 and 31.12.2023
Types of SE according to the current guidelines from the International League of Epilepsy (ILAE) (i.e., nonconvulsive with coma, SE with motor symptoms, focal nonconvulsive SE without coma, and subtle SE
Additional features of the seizure
时间窗: between 01.01.2005 and 31.12.2023
length, level of consciousness at onset, previous epileptic seizures
Clinical neurologic monitoring scores
时间窗: between 01.01.2005 and 31.12.2023
Clinical neurologic monitoring scores (e.g., Richmond Agitation-Sedation Scale (RASS) , Seda-tion-Agitation Scale (SAS), Glasgow Coma Score (GCS), Intensive Care Delirium Screening Checklist (ICDSC), Status Epilepticus Severity Score (STESS))
Laboratory parameters
时间窗: between 01.01.2005 and 31.12.2023
C-Reactive Protein (CRP), albumin, Lactate Dehydrogenase (LDH), Creatin-Kinase (CK), procalcitonin, white blood cell levels, creatinine, liver enzymes, blood gas analyses, metabolic data
Therapeutic features
时间窗: between 01.01.2005 and 31.12.2023
duration, dosage and number of treatment medication, number of antiseizure drugs, invasive procedures, such as intubation, mechanical, ventilation, vasopressors, installation of central lines, nutrition
Monitoring of vital signs
时间窗: between 01.01.2005 and 31.12.2023
blood pressure, heart rate, respiratory rate, oxygen saturation of the blood, body temperature, level of consciousness
ICU Scoring Systems
时间窗: between 01.01.2005 and 31.12.2023
Critical illness severity scores (e.g., acute physiology and chronic health Evaluation (APACHE II), simplified acute physiology score (SAPS II), sequential organ failure assessment (SOFA), etc.)
Outcome measure
时间窗: between 01.01.2005 and 31.12.2023
in-hospital death, survival, survival with neurofunctional alteration, Glasgow Outcome Score, return to neurofunctional premorbid baseline, readmission
次要结局
未报告次要终点