UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of prediction model by vital signs for in-hospital mortality in emergency patients
Title of the study (Brief title)	Comparison of prediction model for in-hospital mortality in emergency patients
Region	Japan

Condition
Condition	emergency patients
Classification by specialty	Emergency medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the quick SOFA score, SIRS criteria without WBC and PaCO2, and Shock Index for predicting the in-hospital mortality of patients transferred to the emergency department by ambulance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	in-hospital mortality
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	adult patients transferred by ambulance to the emergency department of Kumamoto Medical Center between January 2015 and December 2016
Key exclusion criteria	1. out-of-hospital cardiac arrest patients 2. patients for whom one or more vital signs were not available 3. patients whose outcomes were unknown due to admission to other hospitals
Target sample size	16459

Research contact person
Name of lead principal investigator	Masahiro Harada
Organization	National Hospital Organization Kumamoto Medical Center
Division name	Emergency and Critical Care Center
Address	1-5, Ninomaru, Chuoku, Kumamoto, Japan
TEL	096-353-6501
Email	masakoh@kumamed.jp

Public contact
Name of contact person	Masahiro Harada
Organization	National Hospital Organization Kumamoto Medical Center
Division name	Emergency and Critical Care Center
Address	1-5, Ninomaru, Chuoku, Kumamoto, Japan
TEL	096-353-6501
Homepage URL
Email	masakoh@kumamed.jp

Sponsor
Institute	National Hospital Organization Kumamoto Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2018 Year 04 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 01 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Study design: single-site retrospective cohort study The patient of study: adult (age>18 years) patients transferred by ambulance to the emergency department of Kumamoto Medical Center between January 2015 and December 2016 Data collection: 1. pre-hospital medical records for vital signs (consciousness, body temperature, systolic blood pressure, heart rate, and respiratory rate) during transfer to the emergency department 2. in-hospital mortality

Management information
Registered date	2018 Year 04 Month 24 Day
Last modified on	2018 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036913