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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042607
Receipt No. R000048553
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
Date of disclosure of the study information 2020/12/01
Last modified on 2020/11/26

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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
Registered date File name

Research case data
Registered date File name


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