NCT03346382

Brief Summary

Retrospective data analysis, all emergency medical services of the city of Zurich interventions due to epileptic convulsions during June 2013 and December 2014 have been analyzed regarding the type of drug used, its application mode and the application mode based success. Furthermore, children versus adults were compared. Continuous variables were summarized as mean ± standard deviation (SD) and also presented as median \[minimum; maximum\]. Groups were compared using the independent samples t-test. P-values \< 0.05 are considered significant.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

November 2, 2017

Last Update Submit

November 14, 2017

Conditions

Keywords

EpilepsyEmergency medical services

Outcome Measures

Primary Outcomes (1)

  • Which drug (Midazolam versus Diazepam) better stops epileptic seizures in the pre-clinical setting

    In this retrospective trial, all Emergency Medical Services of the city of Zurich interventions due to epileptic seizures during June 2013 and December 2014 are analyzed regarding the two drugs (Midazolam or Diazepam) used, its application mode (intravenous, nasal, intramuscular, rectal) and the application mode based success. Data will be collected regarding these aspects in order to determine if one drug is better than the other one, and which application mode is the most efficient. Furthermore, children versus adults are compared. Continuous variables are summarized as mean ± standard deviation (SD) and also presented as median \[minimum; maximum\]. Groups are compared using the independent samples t-test. P-values \< 0.05 are considered significant.

    follow up up to 1 year

Secondary Outcomes (1)

  • Does the way of application of the drugs (Midazolam versus Diazepam) used in pre-clinical epileptic seizures influence the outcome

    follow up up to 1 year

Eligibility Criteria

AgeUp to 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

retrospective collected data from the emergency medical system "Schutz \& Rettung Zürich", Zurich, Switzerland, over an 18 months period from 01. June 2013 till 31. December 2014 - all calls for epileptic seizures

You may qualify if:

  • emergency calls for epileptic seizures received by the emergency medical system of Zurich,Switzerland,
  • the use of midazolam or diazepam or no drug used.

You may not qualify if:

  • the use of any other first line drug to stop seizures than the two mentioned above e.g. thiopental

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Oliver M Theusinger, MD

    Balgrist University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 17, 2017

Study Start

March 1, 2015

Primary Completion

December 31, 2015

Study Completion

June 30, 2016

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share