Status Epilepticus Population Study (STEPS)

Epileptic Seizures Clinical Trial

Official title:

Status Epilepticus Population Study (STEPS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04204863
• Other study ID #: 2019-00693; me19Sutter5
• Status: Recruiting
• Start date: April 19, 2019
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Raoul Sutter, PD Dr. med
• Phone: +41 61 265 25 25
• Email: Raoul.Sutter[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients younger than 18 years.
• Patients with repetitive epileptic seizures not qualifying for SE.
• Patients with documented refusal of the general consent.

Related Conditions & MeSH terms

• Epilepsy
• Epileptic Seizures
• Seizures
• Status Epilepticus

Intervention

Other:
• collection of patient data
Extract data from the digital medical records, the electroencephalographic and microbiologic database.

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital Aarau (KSA)	Aarau
Switzerland	Clinic for Intensive Care Medicine, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	age, sex	between 01.01.2005 and 31.12.2023
Primary	Data from acute prehospital management by the emergency medical services (EMS)	extracted from the treatment protocols of the EMS	between 01.01.2005 and 31.12.2023
Primary	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 31.12.2023
Primary	Date(s) of seizure(s) captured by electroencephalographic (EEG) data	Date(s) of seizure(s) captured by EEG	between 01.01.2005 and 31.12.2023
Primary	Seizure history and etiology	withdrawal from anti seizure drugs, structural, infectious, or autoimmune causes	between 01.01.2005 and 31.12.2023
Primary	Number and Duration of SE episodes	Number and Duration (time) of SE episodes	between 01.01.2005 and 31.12.2023
Primary	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 31.12.2023
Primary	Additional features of the seizure	length, level of consciousness at onset, previous epileptic seizures	between 01.01.2005 and 31.12.2023
Primary	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 31.12.2023
Primary	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 31.12.2023
Primary	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 31.12.2023
Primary	Outcome measure	in-hospital death, survival, survival with neurofunctional alteration, Glasgow Outcome Score, return to neurofunctional premorbid baseline, readmission	between 01.01.2005 and 31.12.2023
Primary	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 31.12.2023
Primary	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 31.12.2023