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
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
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
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
