UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051847 |
|---|---|
| Receipt number | R000059131 |
| Scientific Title | Influence of Changes in Vital Signs on the Prediction of Adverse Events in Hospitalized Patients Towards the effective use of Rapid Response System |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2023/08/07 12:49:59 |
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Basic information
Public title
Influence of Changes in Vital Signs on the Prediction of Adverse Events in Hospitalized Patients
Acronym
Influence of Changes in Vital Signs on the Prediction of Adverse Events in Hospitalized Patients
Scientific Title
Influence of Changes in Vital Signs on the Prediction of Adverse Events in Hospitalized Patients Towards the effective use of Rapid Response System
Scientific Title:Acronym
Influence of Changes in Vital Signs on the Prediction of Adverse Events in Hospitalized Patients Towards the effective use of RRS
Region
| Japan |
Condition
Condition
All inpatients in general wards
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to use RRS, Rapid Response System, more smoothly and meaningfully by developing an automatic RRS activation system that utilizes this research result and enhances patient safety in the hospital.
Basic objectives2
Others
Basic objectives -Others
Focusing on the vital signs of all patients admitted to the general wards and searching for the amount of changes in these vital signs before adverse events in the hospital.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Unexpected In-Hospital Cardiac Arrest, Unplanned ICU admission
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All hospitalized patients aged 16 and over at St. Marianna University Hospital from January to December 2019.
Key exclusion criteria
patients under the age of 15
patients who have opted out and declared non-participation in the study
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Rimi |
| Middle name | |
| Last name | Tanii |
Organization
St. Marianna University Yokohama Seibu Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
241-0811
Address
Yasushi-sho 1197-1, Asahi-ku, Yokohama city, Kanagawa, Japan
TEL
045-366-1111
rimi.tanii@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Rimi |
| Middle name | |
| Last name | Tanii |
Organization
St. Marianna University Yokohama Seibu Hospital
Division name
Department of Emergency and Critical Care Medicine
Zip code
241-0811
Address
Yasushi-sho 1197-1, Asahi-ku, Yokohama city, Kanagawa, Japan
TEL
045-366-1111
Homepage URL
rimi.tanii@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University
Address
Sugao 2-16-1, Miyamae-ku, Kawasaki city, Kanagawa, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 07 | 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
3170
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
| 2022 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Time-series data [blood pressure, pulse, body temperature, respiratory rate, SpO2, state of consciousness, Presence/absence measured by the nurse and recorded in the electronic health record
2. Hospitalization information of each patient (including date and time, ward, department, hospitalization route including use of ambulance, planned/urgent hospitalization, etc.), discharge information (ward at discharge, outcome), transfer between wards, etc. Reason/destination, presence/absence of surgery, presence/absence of ICU admission
3. List and details of unexpected in-hospital death, unexpected in-hospital cardiac arrest, and unplanned ICU admission
Management information
Registered date
| 2023 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059131
