UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055246 |
|---|---|
| Receipt number | R000063130 |
| Scientific Title | Associatn with eight nutritional screening and the Global Leadership Initiative on Malnutrition criteria in patient undergoing hemodialysis. |
| Date of disclosure of the study information | 2024/09/01 |
| Last modified on | 2025/02/13 09:33:38 |
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Basic information
Public title
Association with eight nutritional screening and the Global Leadership Initiative on Malnutrition criteria in patient undergoing hemodialysis.
Acronym
Associatn with eight nutritional screening and the Global Leadership Initiative on Malnutrition criteria in patient undergoing hemodialysis.
Scientific Title
Associatn with eight nutritional screening and the Global Leadership Initiative on Malnutrition criteria in patient undergoing hemodialysis.
Scientific Title:Acronym
Associatn with eight nutritional screening and the Global Leadership Initiative on Malnutrition criteria in patient undergoing hemodialysis.
Region
| Japan |
Condition
Condition
End-stage kidney disease, hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We clarify that which nutritional-screening is appropiate to GLIM criteria in patient undergoing hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cross-sectional study: Sensitivity and specificity between nutriional risk of Nutritional Risk Screening 2002 (NRS-2002), Malnutritional Universal Screening Tool (MUST), Mini Nutritional Assessmnet-short form (MNA-SF), Malnutrition Screening Tool (MST), Malnutrition-Inflammation Score (MIS), Nutritional Risk Index-Japanese Hemodialysis (NRI-JH), modified simple Protein-eEnergy Wasting score (mPEW socre), Geriatric Nutritional Rsik Index (GNRI) and malnutrition diagnosis of GLIM criteria.
Cohort study: Survival time until March 31, 2029.
Key secondary outcomes
Cross-sectional study: kappa coefficient, likehood ratio, area under curve and cut-off point of each nutritional screening for malnutrition diagnosis of GLIM criteria.
Cohort study: hospitalization until March 31, 2029.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Out patient undergoing hemodialysis or hemodiafiltation, dialysis vintage more than two years, three times dialysis in a week.
Key exclusion criteria
More than six hour or less than four hours in a dialysis, only himofiltration, combination of pertoneal dialysis, patient with tube feeding, defect of limb, difficluty of answering qustion.
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Kou |
| Middle name | |
| Last name | Kitabayashi |
Organization
Shinkohkai Murakami-Kinen Hospital
Division name
Department of Nutrition
Zip code
958-0034
Address
204-1, matuyama, murakami-si, Niigata, Japan
TEL
0254-52-1229
whm13002@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kou |
| Middle name | |
| Last name | Kitabayashi |
Organization
Shinkohkai Murakami-Kinen Hospital
Division name
Department of Nutrition
Zip code
958-0034
Address
204-1, matuyama, murakami-si, Niigata, Japan
TEL
0254-52-1229
Homepage URL
whm13002@nuhw.ac.jp
Sponsor or person
Institute
Shinkokai Murakami-Kinen Hospital
Institute
Department
Personal name
Kou Kitabaashi
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics review committee of Shinkohkai Murakami-Kinen Hospital
Address
204-1, matuyama, murakami-si, Niigata, Japan
Tel
0254-52-1229
kinen.eiyo@shinkohkai.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
新光会村上記念病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | 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
Terminated
Date of protocol fixation
| 2024 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, muscle mass is evaluated used arm muscle area and calf circumference at after dialysis.
We define less than 10 percentile value of arm muscle area and calf circumference as low muscle mass.
Management information
Registered date
| 2024 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063130
