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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043593
Receipt No. 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 2021/04/07

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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
Email 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
Email r.nakashima.s.h@gmail.com

Sponsor
Institute Kumamoto University
Institute
Department

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
Email 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
Date trial data considered complete
Date analysis concluded

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
2021 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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