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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042970
Receipt No. 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 2021/01/11

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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
Email 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
Email jp.haruna@hotmail.co.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

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
Email 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 Open public recruiting
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
2021 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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