UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043593 |
|---|---|
| Receipt number | R000049758 |
| Scientific Title | The study establishing predictive score of successful prehospital infusion to shock patient by emergency life-saving technician in Oita. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/10/13 23:19:42 |
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Basic information
Public title
The study establishing predictive score of successful prehospital infusion to shock patient by emergency life-saving technician in Oita.
Acronym
The study establishing predictive score of successful prehospital infusion to shock patient.
Scientific Title
The study establishing predictive score of successful prehospital infusion to shock patient by emergency life-saving technician in Oita.
Scientific Title:Acronym
The study establishing predictive score of successful prehospital infusion to shock patient.
Region
| Japan |
Condition
Condition
shock
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish predictive score of successful prehospital infusion to shock patient by emergency life-saving technician. This score is derived from vital signs or physical findings in prehospital situation.
Basic objectives2
Others
Basic objectives -Others
To analyze relation between prehospital infusion by emergency life-saving technician and short term mortality.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success or failure of infusion
Key secondary outcomes
Survival rate at 7 days after transferred to hospital
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Successful or unsuccessful cases of prehospital infusion to shock patients performed by emergency life-saving technician in Oita prefecture.
Key exclusion criteria
The case transferred hospital to hospital
Hypoglycemic patients without shock
The case of CPA
The case shifted to CPA before arriving hospital
Target sample size
190
Research contact person
Name of lead principal investigator
| 1st name | Nakashima |
| Middle name | |
| Last name | Ryuta |
Organization
Kumamoto University
Division name
Graduate school of Medical Sciences
Zip code
8608556
Address
1-1-1, Honjo, Chuo, Kumamoto-city, Kumamoto, Japan
TEL
096-373-7214
r.nakashima.s.h@gmail.com
Public contact
Name of contact person
| 1st name | Nakashima |
| Middle name | |
| Last name | Ryuta |
Organization
Saiseikai Hita Hospital
Division name
Department of Emergency Medicine
Zip code
8771292
Address
643-7, Miwa, Hita-city, Oita, Japan
TEL
0973241100
Homepage URL
r.nakashima.s.h@gmail.com
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saiseikai Hita Hospital
Address
643-7, Miwa, Hita-city, Oita, Japan
Tel
0973241100
r.nakashima.s.h@gmail.com
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
| 2021 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 31 | Day |
Other
Other related information
We collect data: patient's age, patient's sex, doctor's activity on site, patient's comorbidity, type of shock, vital sign and physical findings on site, time coarse, years of experience of technicians in field, infusion volume and speed.
Management information
Registered date
| 2021 | Year | 03 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049758
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
