- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03860467
Epileptic Seizures in Intensive Care Units
June 1, 2022 updated by: University Hospital, Basel, Switzerland
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Basel, Switzerland, 4031
- Clinic for Intensive Care Medicine, University Hospital Basel
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All adult patients (i.e., ≥18 years of age) admitted to the ICUs at the University Hospital Basel that suffered from one or more epileptic seizures (detected clinically and/or by EEG) during their ICU-stay
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of epileptic seizures
Time Frame: between 01.01.2005 and 19.12.2018
|
Frequency of all epileptic seizures in the ICU
|
between 01.01.2005 and 19.12.2018
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of epileptic seizures captured by EEG
Time Frame: between 01.01.2005 and 19.12.2018
|
Number of epileptic seizures captured by EEG without overt clinical seizure presentation in the ICU
|
between 01.01.2005 and 19.12.2018
|
Number of epileptic seizures diagnosed on the basis of clinical symptoms alone
Time Frame: between 01.01.2005 and 19.12.2018
|
Number of epileptic seizures diagnosed on the basis of clinical symptoms alone in the ICU
|
between 01.01.2005 and 19.12.2018
|
Length of epileptic seizure (time)
Time Frame: between 01.01.2005 and 19.12.2018
|
Duration of epileptic seizure
|
between 01.01.2005 and 19.12.2018
|
Semiological feature of epileptic seizure (i.e. seizure types)
Time Frame: between 01.01.2005 and 19.12.2018
|
Semiological feature of epileptic seizure (i.e.
seizure types) emerging in ICU-patients
|
between 01.01.2005 and 19.12.2018
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Raoul Sutter, PD Dr. med, Clinic for Intensive Care Medicine, University Hospital Basel
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2019
Primary Completion (Actual)
April 30, 2022
Study Completion (Actual)
April 30, 2022
Study Registration Dates
First Submitted
February 26, 2019
First Submitted That Met QC Criteria
February 27, 2019
First Posted (Actual)
March 4, 2019
Study Record Updates
Last Update Posted (Actual)
June 2, 2022
Last Update Submitted That Met QC Criteria
June 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-02361; me19Sutter
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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