UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008376 |
|---|---|
| Receipt number | 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 06:10:45 |
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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
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
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009847
