UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012045 |
|---|---|
| Receipt number | R000014079 |
| Scientific Title | Rapid Response System (RRS) Data Registry in Multi-centers in Japan |
| Date of disclosure of the study information | 2013/10/16 |
| Last modified on | 2016/04/21 17:53:57 |
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Basic information
Public title
Rapid Response System (RRS) Data Registry in Multi-centers in Japan
Acronym
RRS Data Registry
Scientific Title
Rapid Response System (RRS) Data Registry in Multi-centers in Japan
Scientific Title:Acronym
RRS Data Registry
Region
| Japan |
Condition
Condition
All disease
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the efficacy of RRS in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ratio of in-hospital unexpected death
Ratio of in-hospital mortality
Number of RRS activations
Number of Unexpected ICU transfer
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
RRS-team activated cases, which meet the criteria.
Key exclusion criteria
Under 18 years old (the criteria not determined)
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeki Fujitani |
Organization
St. Marianna University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
Address
2-16-1,Sugao,Miyamae-ku,Kawasaki-shi, Kanagawa-ken, Japan
TEL
044-977-8111
shigekifujitani@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsuke Fujiwara |
Organization
NHO Uresino Medical Center
Division name
Department of Emergency medicine
Zip code
Address
2436, Shimojuku hei, Ureshino town, Ureshino city, Saga-ken, Japan
TEL
0954-43-1120
Homepage URL
http://hospital-em.net/
gearorange@gmail.com
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
| 2013 | Year | 10 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | 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
A Prospective, Multi-center Investigation
Management information
Registered date
| 2013 | Year | 10 | Month | 16 | Day |
Last modified on
| 2016 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014079
