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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03860467
Other study ID # 2018-02361; me19Sutter
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date April 30, 2022

Study information

Verified date June 2022
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This retrospective observational cohort study is to assess and analyze clinical, electroencephalographic, laboratory, comorbidity, and treatment characteristics of Intensive care unit (ICU)-patients with epileptic seizures and to subsequently compare their characteristics with ICU-patients with status epilepticus (SE).


Description:

The aim of this retrospective observational cohort study is to get further insight into adult patients with epileptic seizures in ICUs in an academic tertiary medical care center regarding frequency, clinical and electroencephalogram (EEG) characteristics, treatment, course and outcome. This data could help understanding the epidemiology (including risk factors, influence of EEG), and to guide management and improve outcomes of affected patients.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - admitted to the ICU at the University Hospital Basel - suffered from one or more epileptic seizures (detected clinically and/or by EEG) during their ICU-stay Exclusion Criteria: - patients with epileptic seizures transforming into Status epilepticus (SE)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
collection of patient data
Patient data will be collected using the in-house digital patient record systems and the local digital electroencephalogram (EEG)-database

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Frequency of epileptic seizures Frequency of all epileptic seizures in the ICU between 01.01.2005 and 19.12.2018
Secondary Number of epileptic seizures captured by EEG Number of epileptic seizures captured by EEG without overt clinical seizure presentation in the ICU between 01.01.2005 and 19.12.2018
Secondary Number of epileptic seizures diagnosed on the basis of clinical symptoms alone Number of epileptic seizures diagnosed on the basis of clinical symptoms alone in the ICU between 01.01.2005 and 19.12.2018
Secondary Length of epileptic seizure (time) Duration of epileptic seizure between 01.01.2005 and 19.12.2018
Secondary Semiological feature of epileptic seizure (i.e. seizure types) Semiological feature of epileptic seizure (i.e. seizure types) emerging in ICU-patients between 01.01.2005 and 19.12.2018
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