UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055067 |
|---|---|
| Receipt number | R000062908 |
| Scientific Title | Survey of the nutrition therapy practice in ICUs and HCUs with/without early nutrition intervention and management fee in Japan |
| Date of disclosure of the study information | 2024/07/24 |
| Last modified on | 2024/07/24 20:39:45 |
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Basic information
Public title
Survey of the nutrition therapy practice in ICUs and HCUs with/without early nutrition intervention and management fee in Japan
Acronym
Survey of the nutrition therapy practice in ICUs and HCUs with/without early nutrition intervention and management fee in Japan
Scientific Title
Survey of the nutrition therapy practice in ICUs and HCUs with/without early nutrition intervention and management fee in Japan
Scientific Title:Acronym
Survey of the nutrition therapy practice in ICUs and HCUs with/without early nutrition intervention and management fee in Japan
Region
| Japan |
Condition
Condition
Pediatric and adult critically ill patients
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand the current status of nutrition therapy in critically ill patients in Japan by collecting information on the calculation of additions to the Additional Fee for Early Nutrition Intervention and related nutrition screening methods, nutrition assessment items, methods for setting nutritional targets, and nutrition monitoring items on a daily basis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Nutrition practices related to the calculation of the additional payment for early nutrition intervention management, including methods for nutrition screening, nutrition assessment items, setting nutritional targets, and daily nutrition monitoring items.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Medical institutions with ICUs and HCUs nationwide.
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Joji |
| Middle name | |
| Last name | Kotani |
Organization
Kobe University
Division name
Graduate School of Medicine Department of Disaster and Emergency Medicine
Zip code
650-0017
Address
5-2, Kusunokucho 7-chome, Chuo-ku, Kobe
TEL
078-382-6521
kotanijo@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoka |
| Middle name | |
| Last name | Takaoka |
Organization
Public University Corporation Yokohama City University Graduate School of Medicine
Division name
Master's Degree Program, Department of Biological Regulation and Anesthesiology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2918
Homepage URL
t246503f@yokohama-cu.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital Clinical & Translational Research Center
Address
7-5-2 Kusunokucho, Chuo-ku, Kobe
Tel
078-382-5400
ctrcpj-kenkyukanrijimu@med.kobe
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
| 2024 | Year | 07 | Month | 24 | 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
| 2024 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Multifacility Questionnaire Survey
Management information
Registered date
| 2024 | Year | 07 | Month | 24 | Day |
Last modified on
| 2024 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062908
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
