UMIN-CTR Clinical Trial

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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