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Emergency Medical Services and Epilepsy in Switzerland

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03346382
Recruitment Status : Completed
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Theusinger Oliver M., Balgrist University Hospital

Tracking Information
First Submitted Date November 2, 2017
First Posted Date November 17, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date March 1, 2015
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 14, 2017)
Which drug (Midazolam versus Diazepam) better stops epileptic seizures in the pre-clinical setting [ Time Frame: follow up up to 1 year ]
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: November 14, 2017)
Does the way of application of the drugs (Midazolam versus Diazepam) used in pre-clinical epileptic seizures influence the outcome [ Time Frame: follow up up to 1 year ]
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Emergency Medical Services and Epilepsy in Switzerland
Official Title Treatment of Epilepsy in Children and Adults in the Emergency Medical Services of the City of Zurich, Switzerland - Midazolam Versus Diazepam - A Retrospective Analysis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 14, 2017)
584
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2016
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • the use of any other first line drug to stop seizures than the two mentioned above e.g. thiopental
Sex/Gender
Sexes Eligible for Study: All
Ages up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03346382
Other Study ID Numbers OMT 01012015 SRZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Theusinger Oliver M., Balgrist University Hospital
Study Sponsor Theusinger Oliver M.
Collaborators Not Provided
Investigators
Study Chair: Oliver M Theusinger, MD Balgrist University Hospital
PRS Account Balgrist University Hospital
Verification Date November 2017