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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016871
Receipt No. R000019583
Scientific Title Current Status of Nutritional Practice In Japan: A Multicenter Observational Study
Date of disclosure of the study information 2015/03/25
Last modified on 2018/12/15

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Basic information
Public title Current Status of Nutritional Practice In Japan: A Multicenter Observational Study
Acronym ICU-PRO study
Scientific Title Current Status of Nutritional Practice In Japan: A Multicenter Observational Study
Scientific Title:Acronym ICU-PRO study
Region
Japan

Condition
Condition Patients who receive mechanical ventilation for at least 24 hours and are in the ICU for longer than 72 hours
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1. To assess current status of nutritional practice in Japanese intensive care units.
2. To assess the relationship between amino acid and protein intakes and outcomes in patients with critical illnesses.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rehabilitation status on day of discharge from the intensive care unit.
Key secondary outcomes 28 days mortality

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 Patients who receive mechanical ventilation for at least 24 hours and are in the ICU for longer than 72 hours.
Key exclusion criteria Patients who ask us not to use their clinical information.
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoaki Yatabe
Organization Kochi Medical School
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL 088-880-2471(+81-88-880-2471)
Email yatabe@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoaki Yatabe
Organization Kochi Medical School
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi, Japan
TEL 088-880-2471(+81-88-880-2471)
Homepage URL
Email yatabe@kochi-u.ac.jp

Sponsor
Institute Kochi Medical School
Institute
Department

Funding Source
Organization Kochi University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) JSPS KAKENHI
Grant-in-Aid for Scientific Research(C)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 03 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/30541003
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
2014 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1)Age,gender,height,weight
2)The day for ICU admission and discharge
3)Reasons for ICU admission
4)The status(dead or alive) at 28 days after ICU admission.
5)APACHE II and SOFA score
6)Type and amount of nutrition received on ICU day 3,day 7, and day of discharge from the ICU.
7)Free-ventilator day during 28 days, length of ICU and hospital stays, mortality, and rehabilitation status.

Management information
Registered date
2015 Year 03 Month 22 Day
Last modified on
2018 Year 12 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019583

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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