UMIN-CTR Clinical Trial

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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