UMIN-CTR Clinical Trial

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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