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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008376
Receipt No. R000009847
Scientific Title Trial to expand range of treatment by paramedic an emergency medical technician
Date of disclosure of the study information 2012/07/08
Last modified on 2013/07/04

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Basic information
Public title Trial to expand range of treatment by paramedic an emergency medical technician
Acronym Trial to expand range of treatment by paramedic an emergency medical technician
Scientific Title Trial to expand range of treatment by paramedic an emergency medical technician
Scientific Title:Acronym Trial to expand range of treatment by paramedic an emergency medical technician
Region
Japan

Condition
Condition hypoglycemia
Asthma attack
Shock
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test efficacy and safety of following three treatments by paramedic an emergency medical technician
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. improvement of consciousness
2. time from the scene to hospital
3. improvement of shock index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 observation
Interventions/Control_2 1. measurement of blood glucose, intravenous injection of glucose
2. inhalation of SABA
3. drip infusion
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. hypoglycemia
JCS 10 <, usage of anti-diabetic medication, blood glucose 50mg/ml>
2. Asthma
has own SABA, but cannot inhalate him/herself
3. Shock
4. crush syndrome
Key exclusion criteria 1. hypoglycemia
Other causes are not plausible.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Noguchi
Organization Fujita Health University
Division name Emergency medicine
Zip code
Address 1-98 Dengakugakubo, Kutsukake-chou, Toyoake-city, Aichi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuyoshi Urashima
Organization Jikei University School of Medicine
Division name Division of Molecular Epidemiology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization MHLW Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2013 Year 01 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 26 Day
Date trial data considered complete
2013 Year 03 Month 27 Day
Date analysis concluded
2013 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 08 Day
Last modified on
2013 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009847

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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