NCT03860467

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 4, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

June 2, 2022

Status Verified

June 1, 2022

Enrollment Period

2.4 years

First QC Date

February 26, 2019

Last Update Submit

June 1, 2022

Conditions

Keywords

Status epilepticusElectroencephalogramIntensive Care Unit

Outcome Measures

Primary Outcomes (1)

  • Frequency of epileptic seizures

    Frequency of all epileptic seizures in the ICU

    between 01.01.2005 and 19.12.2018

Secondary Outcomes (4)

  • Number of epileptic seizures captured by EEG

    between 01.01.2005 and 19.12.2018

  • Number of epileptic seizures diagnosed on the basis of clinical symptoms alone

    between 01.01.2005 and 19.12.2018

  • Length of epileptic seizure (time)

    between 01.01.2005 and 19.12.2018

  • Semiological feature of epileptic seizure (i.e. seizure types)

    between 01.01.2005 and 19.12.2018

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • patients with epileptic seizures transforming into Status epilepticus (SE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SeizuresStatus Epilepticus

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Raoul Sutter, PD Dr. med

    Clinic for Intensive Care Medicine, University Hospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 4, 2019

Study Start

December 1, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

June 2, 2022

Record last verified: 2022-06

Locations