UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055695 |
|---|---|
| Receipt number | R000062803 |
| Scientific Title | Usefulness of Early Warning Score for Rapid Response System Activation: a observational study |
| Date of disclosure of the study information | 2024/10/02 |
| Last modified on | 2025/10/02 12:59:02 |
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Basic information
Public title
Usefulness of Early Warning Score for Rapid Response System Activation: a observational study
Acronym
Usefulness of Early Warning Score for Rapid Response System Activation
Scientific Title
Usefulness of Early Warning Score for Rapid Response System Activation: a observational study
Scientific Title:Acronym
Usefulness of Early Warning Score for Rapid Response System Activation
Region
| Japan |
Condition
Condition
Patient with Rapid Response System activated
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate whether the hospital's rapid response system (Rapid Response System :RRS) is properly activated.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NEWS evaluated by RRS staff at the time of patient contact
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with RRS activated and a record of RRS activity
2) Patients whose EWS was calculated and screened by RRS staff during hospitalization
Key exclusion criteria
None
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Yokohama City University Hospital
Division name
Department of anesthesiology and critical care medicine
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
81457872800
yokose_p12@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Yokose |
Organization
Yokohama City University Hospital
Division name
Department of anesthesiology and critical care medicine
Zip code
236004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
TEL
81457872800
Homepage URL
yokose_p12@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Masashi Yokose
Funding Source
Organization
Self funding
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
The institutional ethics commitee of Yokohama City University Hospital
Address
3-9, Fukuura, Kanazawa-ku, Yokohama, Japan
Tel
+81457872800
rinri@yokohama-cu.ac.jp
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
| 2024 | Year | 10 | Month | 02 | 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
221
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients characteristics
1) age, sex, height, weight, past history, comorbidity, DNAR or not
2) Internal medicine or surgery, main disease
3) RRS activation location, reason for activation, and time of activation
4) NEWS
5) EWS
6) Intervention by RRS and details of intervention
7) Outcome
8) WBC, CRP
9) DNAR acquisition after RRS activation
10) Survival discharge, transfers, death, length of hospital stay, length of ICU stay
Statistical analysis
Primary outcome
Descriptions with and without RRS intervention
Use t-tests for between-group comparisons
ANCOVA will be used to adjust for covariate.
Predictive ability of NEWS to predict the presence or absence of intervention by RRS: ROC(Delong)
Logistic regression analysis:
Object variable, Presence or absence of any intervention
explanatory variables, Age, sex, internal medicine or surgery, NEWS, Inflammation
Secondary outcome
1) Patient background: Description using mean or median
2) Reason for actiavting RRS:Frequency of each item in the RRS activation criteria
3) EWS scores: Description using mean or median Use t-tests for between-group comparisons
Management information
Registered date
| 2024 | Year | 10 | Month | 01 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062803
