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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04333082
Other study ID # 2020-00538; me20Sutter
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 22, 2020
Est. completion date August 3, 2022

Study information

Verified date February 2024
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study is to investigate the effects of different treatment characteristics regarding the use of intravenous anesthetic drugs (IVADs) as a rescue treatment for refractory Status epilepticus (RSE) on course and outcome. A retrospective data extraction from the digital medical records, the electroencephalographic and microbiologic database of all consecutive adult patients with Status epilepticus (SE) admitted to the University Hospital Basel is undertaken.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date August 3, 2022
Est. primary completion date August 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - diagnosed SE between 2005 and 2019 who have been treated at intensive care units (ICUs) of the University Hospital of Basel Exclusion Criteria: - Patients with repetitive epileptic seizures not qualifying for SE or RSE - Patients with documented refusal of the general in-house consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Data collection
collection of patient data Data collection (demographics, prehospital management, duration of ICU and hospital stay, destination at discharge, date(s) of seizure(s), electroencephalographic (EEG) data, seizure history and etiology, number and duration of SE episodes, medication, types of SE according to the current guidelines from the International League of Epilepsy (ILAE), neuroimaging features, comorbidities, laboratory parameters, complications during and after SE , laboratory testing, vital signs, fluid balance) will be performed from the digital medical records, the electroencephalographic and microbiologic database of patients

Locations

Country Name City State
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, 

References & Publications (1)

Fisch U, Junger AL, Baumann SM, Semmlack S, De Marchis GM, Hunziker S, Ruegg S, Marsch S, Sutter R. Association Between Induced Burst Suppression and Clinical Outcomes in Patients With Refractory Status Epilepticus: A 9-Year Cohort Study. Neurology. 2023 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary number of in- hospital death number of in- hospital death at baseline (T0)
Secondary neurofunctional alteration assessed by Glasgow Outcome Score (GOS) neurofunctional alteration assessed by Glasgow Outcome Score (GOS). The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery at baseline (T0)
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