UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032365
Receipt number R000036913
Scientific Title Comparison of prediction model by vital signs for in-hospital mortality in emergency patients
Date of disclosure of the study information 2018/04/24
Last modified on 2018/04/24 14:40:31

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Basic information

Public title

Comparison of prediction model by vital signs for in-hospital mortality in emergency patients

Acronym

Comparison of prediction model for in-hospital mortality in emergency patients

Scientific Title

Comparison of prediction model by vital signs for in-hospital mortality in emergency patients

Scientific Title:Acronym

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

1st name
Middle name
Last name Masahiro Harada

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Emergency and Critical Care Center

Zip code


Address

1-5, Ninomaru, Chuoku, Kumamoto, Japan

TEL

096-353-6501

Email

masakoh@kumamed.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Harada

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Emergency and Critical Care Center

Zip code


Address

1-5, Ninomaru, Chuoku, Kumamoto, Japan

TEL

096-353-6501

Homepage URL


Email

masakoh@kumamed.jp


Sponsor or person

Institute

National Hospital Organization Kumamoto Medical Center

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2017 Year 08 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036913


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name