Status Epilepticus Unicenter Population (STEP UP) Study

Study Overview
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Brief Summary
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The aim of this observational single-center 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).

Official Title
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Status Epilepticus Unicenter Population (STEP UP) Study

Conditions
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Epileptic Seizures

Intervention / Treatment
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* Other: collection of patient data


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (i.e., patients ≥18 years of age) with diagnosed SE between 2005 and 2020 who have been treated at the University Hospital of Basel. Exclusion Criteria: Patients younger than 18 years. Patients with repetitive epileptic seizures not qualifying for SE. Patients with documented refusal of the general consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SE patients<br> | Other: collection of patient data<br>* Extract data from the digital medical records, the electroencephalographic and microbiologic database.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | age, sex | between 01.01.2005 and 19.12.2020 | 
| Data from acute prehospital management by the emergency medical services (EMS) | extracted from the treatment protocols of the EMS | between 01.01.2005 and 19.12.2020 | 
| Duration of ICU (intensive care unit) and hospital stay, and destination at discharge | Duration of ICU (intensive care unit) and hospital stay, and destination at discharge | between 01.01.2005 and 19.12.2020 | 
| Date(s) of seizure(s) captured by electroencephalographic (EEG) data | Date(s) of seizure(s) captured by EEG | between 01.01.2005 and 19.12.2020 | 
| Seizure history and etiology | withdrawal from anti seizure drugs, structural, infectious, or autoimmune causes | between 01.01.2005 and 19.12.2020 | 
| Number and Duration of SE episodes | Number and Duration (time) of SE episodes | between 01.01.2005 and 19.12.2020 | 
| Types of SE | 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 | between 01.01.2005 and 19.12.2020 | 
| Additional features of the seizure | length, level of consciousness at onset, previous epileptic seizures | between 01.01.2005 and 19.12.2020 | 
| ICU Scoring Systems | 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.) | between 01.01.2005 and 19.12.2020 | 
| Clinical neurologic monitoring scores | 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)) | between 01.01.2005 and 19.12.2020 | 
| Laboratory parameters | C-Reactive Protein (CRP), albumin, Lactate Dehydrogenase (LDH), Creatin-Kinase (CK), procalcitonin, white blood cell levels, creatinine, liver enzymes, blood gas analyses, metabolic data | between 01.01.2005 and 19.12.2020 | 
| Outcome measure | in-hospital death, survival, survival with neurofunctional alteration, Glasgow Outcome Score, return to neurofunctional premorbid baseline, readmission | between 01.01.2005 and 19.12.2020 | 
| Therapeutic features | duration, dosage and number of treatment medication, number of antiseizure drugs, invasive procedures, such as intubation, mechanical, ventilation, vasopressors, installation of central lines, nutrition | between 01.01.2005 and 19.12.2020 | 
| Monitoring of vital signs | blood pressure, heart rate, respiratory rate, oxygen saturation of the blood, body temperature, level of consciousness | between 01.01.2005 and 19.12.2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Status epilepticus, Electroencephalogram