UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052779 |
|---|---|
| Receipt number | R000060185 |
| Scientific Title | Association between nutritional assessment using GLIM criteria and prognosis in patients with acute heart failure |
| Date of disclosure of the study information | 2023/11/17 |
| Last modified on | 2023/12/13 15:21:54 |
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Basic information
Public title
Association between nutritional assessment using GLIM criteria and prognosis in patients with acute heart failure
Acronym
Association between nutritional assessment using GLIM criteria and prognosis in patients with acute heart failure
Scientific Title
Association between nutritional assessment using GLIM criteria and prognosis in patients with acute heart failure
Scientific Title:Acronym
Association between nutritional assessment using GLIM criteria and prognosis in patients with acute heart failure
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology | 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 criteria is useful as nutritional assessment for acute heart failure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Combined end point of death or readmission after 6 months from the date of ICU discharge
Key secondary outcomes
Readmission after 3 months from the date of ICU discharge
Mortality after 3 months from the date of ICU discharge
ADL 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 due to acute heart failure
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 do not consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Saijo |
Organization
Osaka Rosai Hospital
Division name
Department of Nutrition Management
Zip code
5918025
Address
1179-3, Nagasone-cho, kita-ku, Sakai, Osaka, Japan
TEL
0722523561
eiyokanrishitsucho@osakah.johas.go.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Saijo |
Organization
Osaka Rosai Hospital
Division name
Department of Nutrition Management
Zip code
5918025
Address
1179-3, Nagasone-cho, kita-ku, Sakai, Osaka, Japan
TEL
0722523561
Homepage URL
eiyokanrishitsucho@osakah.johas.go.jp
Sponsor or person
Institute
Osaka Rosai Hospital
Institute
Department
Personal name
Takeshi Saijo
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 Osaka Rosai Hospital
Address
1179-3, Nagasone-cho, kita-ku, Sakai, Osaka, Japan
Tel
0722523561
soumukatyou@osakah.johas.go.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
大阪労災病院（大阪府）、近森病院（高知県）、済生会済生会横浜市東部病院（神奈川県）、名古屋ハートセンター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 17 | 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 | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 11 | 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 | 11 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060185
| 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 |
