UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052378 |
|---|---|
| Receipt number | R000059741 |
| Scientific Title | Global Leadership Initiative on Malnutrition in Acute phase with Muscle echography of Upper Arm project: GLIM-AMUA project |
| Date of disclosure of the study information | 2023/10/02 |
| Last modified on | 2023/11/09 18:27:47 |
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Basic information
Public title
Global Leadership Initiative on Malnutrition in Acute phase with Muscle echography of Upper Arm project: GLIM-AMUA project
Acronym
Global Leadership Initiative on Malnutrition in Acute phase with Muscle echography of Upper Arm project: GLIM-AMUA project
Scientific Title
Global Leadership Initiative on Malnutrition in Acute phase with Muscle echography of Upper Arm project: GLIM-AMUA project
Scientific Title:Acronym
Global Leadership Initiative on Malnutrition in Acute phase with Muscle echography of Upper Arm project: GLIM-AMUA project
Region
| Japan |
Condition
Condition
adults patients equal to or more than 18 years admitted to the ICU
Classification by specialty
| Medicine in general | Surgery in general | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether GLIM-AMUA is useful as an acute-phase nutritional assessment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival after 3 months from the date of ICU discharge
Key secondary outcomes
ADL after 3 months from the date of ICU discharge
Readmission after 3 months from the date of ICU discharge
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
Patients admitted to ICU
Patients who are expected to stay in the ICU for more than 48 hours
Patients who can walk independently before admission (including walking with a cane and using a walker)
Key exclusion criteria
Under 18 years old
Patients with injuries or infections in the upper arm
Patients who could not consent
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Miyajima |
Organization
Chikamori Hospital
Division name
Department of Clinical Nutrition
Zip code
7808522
Address
1-1-16, Okawasuji, Kochi, Japan
TEL
0888225231
miyajima_i@y6.dion.ne.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Miyajima |
Organization
Chikamori Hospital
Division name
Department of Clinical Nutrition
Zip code
7808522
Address
1-1-16, Okawasuji, Kochi, Japan
TEL
0888225231
Homepage URL
miyajima_i@y6.dion.ne.jp
Sponsor or person
Institute
Chikamori Hospital
Institute
Department
Personal name
Isao Miyajima
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Chikamori Hospital
Address
1-1-16, Okawasuji, Kochi, Japan
Tel
0888225231
y-wada@chikamori.com
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
近森病院（高知県）、大阪労災病院（大阪）、済生会済生会横浜市東部病院（神奈川県）、横浜市立大学附属病院（神奈川県）、神戸大学医学部附属病院（兵庫県）、日立総合病院（茨城県）、JA広島総合病院（広島県）、近畿大学奈良病院（奈良県）、福島県立医科大学附属病院（福島県）、上尾中央総合病院（埼玉県）、奈良県総合医療センター（奈良県）、JA愛知厚生連豊田厚生病院（愛知県）、国際医療福祉大学成田病院（千葉県）、日本赤十字社医療センター（東京都）、済生会熊本病院（熊本県）、京都大学医学部附属病院（京都府）、竹田綜合病院（福島県）、大阪公立大学医学部附属病院（大阪府）、名古屋ハートセンター（愛知県）、横浜市立みなと赤十字病院（神奈川県）、須賀市立うわまち病院（神奈川県）、虎の門病院（東京都）、聖マリアンナ医科大学病院（神奈川県）、聖マリアンナ医科大学横浜市西部病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059741
