UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039549 |
|---|---|
| Receipt number | R000045101 |
| Scientific Title | Dementia has the stronger correlation to the mortal risk in hemodialysis patients than the presence of diabetes mellitus: An analysis from Mini-Mental State Examination. |
| Date of disclosure of the study information | 2020/02/20 |
| Last modified on | 2020/02/20 17:13:21 |
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Basic information
Public title
Dementia has the stronger correlation to the mortal risk in hemodialysis patients than the presence of diabetes mellitus: An analysis from Mini-Mental State Examination.
Acronym
Dementia has the stronger correlation to the mortal risk in hemodialysis patients than the presence of diabetes mellitus.
Scientific Title
Dementia has the stronger correlation to the mortal risk in hemodialysis patients than the presence of diabetes mellitus: An analysis from Mini-Mental State Examination.
Scientific Title:Acronym
Dementia has the stronger correlation to the mortal risk in hemodialysis patients than the presence of diabetes mellitus.
Region
| Japan |
Condition
Condition
Patients with diabetes undergoing hemodialysis.
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the factors between the mortal risks and cognitive functions in elderly hemodialysis patients with diabetes mellitus tested by Mini-Mental State Examination.
Basic objectives2
Others
Basic objectives -Others
Mortal rate of hemodialysis patients with diabetes mellitus.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortal rate
Mini-Mental State Examination score
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
hemodialysis patients
Key exclusion criteria
Patients who are considered to be inappropriate for participation in this study by the investigator's judgement.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Miyazaki |
Organization
Nagasaki Kidney Hospital
Division name
Department of Nursing
Zip code
850-0032
Address
5-1 Kouzenmachi, Nagasaki
TEL
095-824-1101
satoshi2754@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Miyazaki |
Organization
Nagasaki Kidney Hospital
Division name
Department of Nursing
Zip code
850-0032
Address
5-1 Kouzenmachi, Nagasaki
TEL
095-824-1101
Homepage URL
satoshi2754@yahoo.co.jp
Sponsor or person
Institute
Nagasaki Kidney Hospital
Department of nephrology
Institute
Department
Personal name
Funding Source
Organization
Not Applicable
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
Nagasaki Kidney Hospital Ethics Committee
Address
5-1 Kouzenmachi, Nagasaki
Tel
095-824-1101
m-yamashita@nagajin.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 02 | Month | 20 | 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
112
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate the factors between the mortal risks and cognitive functions in elderly hemodialysis patients with diabetes mellitus tested by Mini-Mental State Examination.
Management information
Registered date
| 2020 | Year | 02 | Month | 20 | Day |
Last modified on
| 2020 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045101
