UMIN-CTR Clinical Trial

Basic information
Public title	Survey of nutritional management for patients in the ICU and association between prescribed doses of nutrients and clinical outcomes in the long-term fasting patients in the ICU : A cohort study using a medical claims database
Acronym	Nutritional management and clinical outcomes in the ICU
Scientific Title	Survey of nutritional management for patients in the ICU and association between prescribed doses of nutrients during fasting period and clinical outcomes in the long-term fasting patients in the ICU : A cohort study using a medical claims database
Scientific Title:Acronym	Nutritional management and clinical outcomes in the ICU
Region	Japan

Condition
Condition	Patients with mechanical ventilation in the ICU
Classification by specialty	Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	(1) To clarify nutritional management for patients in the ICU (2) To investigate the association between prescribed doses of nutrients and clinical outcomes in fasting patients over 7 days after admission to the ICU
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In-hospital mortality
Key secondary outcomes	(1)Length of hospital stay (2)Readmission

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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients admitted to the ICU between January 1, 2010 and June 30, 2020 (2)Patients aged 18 years or older (3)Patients with mechanical ventilation on both 1st and 2nd day in the ICU (4)Patients in the ICU 3 days or more
Key exclusion criteria	(1)Patients who died or were discharged within 7 days in the ICU (2)Patients who received oral feeding within 2 days in the ICU (3)Patients whose height is less than 100 cm or 200 cm or more (4)Patients whose body weight is less than 10 kg or 200 kg or more (5)Patients whose body weight or height data is missing
Target sample size	40000

Research contact person
Name of lead principal investigator	1st name Hideto Middle name Last name Yasuda
Organization	Jichi Medical University Saitama Medical Center
Division name	Emergency Department
Zip code	330-8503
Address	1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL	048-647-2111
Email	yasudahideto@me.com

Public contact
Name of contact person	1st name Yuri Middle name Last name Horikoshi
Organization	Otsuka Pharmaceutical Factory, Inc.
Division name	Medical Affairs Department
Zip code	101-0048
Address	2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
TEL	03-5217-5954
Homepage URL
Email	Horikoshi.Yuri@otsuka.jp

Sponsor
Institute	Jichi Medical University Saitama Medical Center
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Otsuka Pharmaceutical Factory, Inc.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Jichi Medical University Bioethics Committee for Clinical Research, Saitama Medical Center
Address	1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
Tel	048-647-2111(2367)
Email	s-suishin@jichi.ac.jp

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	2020 Year 12 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 11 Month 12 Day
Date of IRB	2020 Year 11 Month 12 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design A cohort study using the medical claims database Data source A medical database provided by Medical Data Vision Co. Ltd. The database is based on the DPC data/medical claims database. The database covers about 23% of all DPC hospitals in Japan. All data is anonymized from the viewpoint of personal information protection. Survey of nutritional management The nutritional management is surveyed based on the prescription and treatment records available in the database. We analyze day of initiation of EN, route of nutritional administration, prescribed dose of parenteral nutrition, and risk factors for long-term fasting. Association between prescribed doses of nutrients and clinical outcomes during fasting period Patients who are fasting over 7 days are divided into two groups based on the prescribed doses of nutrients between 4-7 days. To examine the association between prescribed doses of nutrients and clinical outcomes, multivariable logistic regression analysis adjusting for patient characteristics as confounding factors is performed, and odds ratios and the 95% confidence intervals are estimated.

Management information
Registered date	2020 Year 12 Month 01 Day
Last modified on	2020 Year 11 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048553

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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