Epileptic SeizureNCT03860467
Epileptic Seizures in Intensive Care Units
An observational study of Epileptic Seizure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epileptic Seizure
- What is being tested?
- collection of patient data
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2019to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- patients with epileptic seizures transforming into Status epilepticus (SE)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Intensive Care Medicine, University Hospital Basel
Basel, 4031
About this study
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).
Read the 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.
- Conditions
- Epileptic Seizure
- Being tested
- collection of patient data
- Keywords
- Status epilepticus, Electroencephalogram, Intensive Care Unit
- Medical subject headings
- Seizures, Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of patient dataOther
Patient data will be collected using the in-house digital patient record systems and the local digital electroencephalogram (EEG)-database
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of epileptic seizures
Frequency of all epileptic seizures in the ICU
Measured: between 01.01.2005 and 19.12.2018
Secondary outcomes (4)
Number of epileptic seizures captured by EEG
Number of epileptic seizures captured by EEG without overt clinical seizure presentation in the ICU
Measured: between 01.01.2005 and 19.12.2018
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
Measured: between 01.01.2005 and 19.12.2018
Length of epileptic seizure (time)
Duration of epileptic seizure
Measured: between 01.01.2005 and 19.12.2018
Semiological feature of epileptic seizure (i.e. seizure types)
Semiological feature of epileptic seizure (i.e. seizure types) emerging in ICU-patients
Measured: between 01.01.2005 and 19.12.2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study start1 Dec 2019
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epileptic SeizureStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, PD Dr. med, Principal investigator, Clinic for Intensive Care Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860467
- Sponsor's protocol ID
- 2018-02361; me19Sutter
- Other IDs
- 2018
- Status last verified
- Jun 2022
- First submitted
- 26 Feb 2019
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wagner AS, Semmlack S, Frei A, Ruegg S, Marsch S, Sutter R. Seizures and risks for recurrence in critically ill patients: an observational cohort study. J Neurol. 2022 Aug;269(8):4185-4194. doi: 10.1007/s00415-022-11038-6. Epub 2022 Mar 2.
PubMed 35235003
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epileptic Seizures in Intensive Care Units
- ClinicalTrials.gov ID
- NCT03860467
- Acronym / sponsor ID
- 2018-02361; me19Sutter
- Conditions
- Epileptic Seizure
- Keywords
- Status epilepticus, Electroencephalogram, Intensive Care Unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- patients with epileptic seizures transforming into Status epilepticus (SE)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of patient dataPatient data will be collected using the in-house digital patient record systems and the local digital electroencephalogram (EEG)-database | Other | – |
Primary outcome
Frequency of epileptic seizures
Time frame: between 01.01.2005 and 19.12.2018
Frequency of all epileptic seizures in the ICU
4 secondary outcomes
Number of epileptic seizures captured by EEG
Time frame: 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
Length of epileptic seizure (time)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Derived from this study: PubMed 35235003Wagner AS, Semmlack S, Frei A, Ruegg S, Marsch S, Sutter R. Seizures and risks for recurrence in critically ill patients: an observational cohort study. J Neurol. 2022 Aug;269(8):4185-4194. doi: 10.1007/s00415-022-11038-6. Epub 2022 Mar 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Sutter, PD Dr. med principal investigator
Clinic for Intensive Care Medicine, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epileptic Seizure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of epileptic seizures (time frame: between 01.01.2005 and 19.12.2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03860467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.