UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042970 |
|---|---|
| Receipt number | R000049056 |
| Scientific Title | "The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU". |
| Date of disclosure of the study information | 2021/01/12 |
| Last modified on | 2022/06/09 09:28:19 |
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Basic information
Public title
"The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU".
Acronym
"The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU".
Scientific Title
"The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU".
Scientific Title:Acronym
"The relationship between "Early Warning Score and Nursing Activities Score at ICU Discharge" and " Readmission in ICU".
Region
| Japan |
Condition
Condition
Patients of ICU
Classification by specialty
| Intensive care medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine the relationship between the Early Warning Score and Nursing Activities Score at ICU Discharge and ICU Readmission in patients admitted to the ICU for emergencies.
Basic objectives2
Others
Basic objectives -Others
non
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary outcome of this study is the association between NEWS and NAS and ICU readmission.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older who were admitted urgently to the ICU in our hospital from April 1, 2011 to December 31, 2019.
Key exclusion criteria
1) Patients who died in ICU
(2) Patients admitted to ICU for bed control
(3) Patients whose vital signs were not monitored when they left ICU
3) Patients whose vital signs were not monitored at the time of ICU discharge. 4) Patients who have been re-admitted to ICU more than three times.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | JUNPEI |
| Middle name | |
| Last name | HARUNA |
Organization
Sapporo Medical University, School of Medicine.
Division name
Department of Intensive Care Medicine
Zip code
060-8543
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL
011-611-2111
jp.haruna@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Haruna |
Organization
Sapporo Medical University, School of Medicine.
Division name
Department of Intensive Care Medicine
Zip code
060-8543
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL
0116112111
Homepage URL
jp.haruna@hotmail.co.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
Sapporo medical University
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
Tel
011-611-2111
jp.haruna@icloud.com
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
| 2021 | Year | 01 | Month | 12 | 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
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2021 | Year | 01 | Month | 11 | Day |
Last modified on
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049056
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
