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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044458
Receipt No. R000050788
Scientific Title Relationship between dysphagia asessed by KT balance chart and nutritional index in dialysis patients
Date of disclosure of the study information 2021/06/08
Last modified on 2021/06/07

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Basic information
Public title Relationship between dysphagia asessed by KT balance chart and nutritional index in dialysis patients
Acronym Relationship between dysphagia asessed by KT balance chart and nutritional index in dialysis patients
Scientific Title Relationship between dysphagia asessed by KT balance chart and nutritional index in dialysis patients
Scientific Title:Acronym Relationship between dysphagia asessed by KT balance chart and nutritional index in dialysis patients
Region
Japan

Condition
Condition chronic hemodialysis patients
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the actual condition of dysphagia evaluated using the KT balance chart in hospitalized dialysis patients and the relationship between dysphagia and nutritional index
Basic objectives2 Others
Basic objectives -Others consideration of relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes KT balance chart score
Key secondary outcomes nurtritional index(albumin,GNRI,NRI-JH)

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 Hospitalized dialysis patient
Key exclusion criteria Among inpatients, those for the purpose of chemotherapy, testing, or introducing dialysis

















































Target sample size 100

Research contact person
Name of lead principal investigator
1st name Satoko
Middle name
Last name Notomi
Organization Nagasaki kidney hospital
Division name Department of nutrition
Zip code 850-0032
Address 5-1,Kozenmachi,Nagasaki
TEL 095-824-1101
Email s-notomi@nagajin.jp

Public contact
Name of contact person
1st name Satoko
Middle name
Last name Notomi
Organization Nagasaki kidney hospital
Division name Department nutrition
Zip code 850-0032
Address 5-1,Kozenmachi,Nagasaki
TEL 095-824-1101
Homepage URL
Email s-notomi@nagajin.jp

Sponsor
Institute Nagasaki kidney hospital
Institute
Department

Funding Source
Organization Nagasaki kidney hospital
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 Ethical committee of Nagasaki kidney hospital
Address 5-1,Kozenmachi, Nagasaki
Tel 095-824-1101
Email r-koma@nagajin.jp

Secondary IDs
Secondary IDs YES
Study ID_1 20004
Org. issuing International ID_1 Ethical committee of Nagasaki kidney hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 長崎腎病院(長崎県)

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 08 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
2021 Year 06 Month 03 Day
Date of IRB
2021 Year 06 Month 07 Day
Anticipated trial start date
2021 Year 06 Month 08 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional study
All patients admitted to our facility in July-December 2021 who met the selection criteria

Management information
Registered date
2021 Year 06 Month 07 Day
Last modified on
2021 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050788

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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