UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050656 |
|---|---|
| Receipt number | R000057718 |
| Scientific Title | Consideration of dry weight setting during hemodialysis using serum syndecan-1 concentration measurement |
| Date of disclosure of the study information | 2023/03/23 |
| Last modified on | 2023/03/23 14:35:28 |
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Basic information
Public title
Consideration of dry weight setting during hemodialysis using serum syndecan-1 concentration measurement
Acronym
Measurement of serum syndecan-1 concentration during hemodialysis
Scientific Title
Consideration of dry weight setting during hemodialysis using serum syndecan-1 concentration measurement
Scientific Title:Acronym
Measurement of serum syndecan-1 concentration during hemodialysis
Region
| Japan |
Condition
Condition
End-stage kidney disease requiring hemodialysis
Classification by specialty
| Medicine in general | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will measure blood syndecan-1 in hemodialysis patients and study its relationship with dehydration and dry weight. It is inferred that the promotion of this study may serve as an indicator to determine the optimal dry weight of hemodialysis patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relation between syndecan-1 and water removal rate
Key secondary outcomes
Syndecan-1 Associated with Dry Weight
Association of syndecan-1 with adverse events
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients over 20 years old
Key exclusion criteria
(i) Patients who are judged by their physicians to be inappropriate for inclusion in the program.
(ii) Patients who have requested refusal of information use in an opt-out document.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hideshi |
| Middle name | Okada |
| Last name | Okada |
Organization
Gifu University Graduate School of Medicine
Division name
Emergency and Disaster Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
0582306448
hideshi@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideshi |
| Middle name | Okada |
| Last name | Okada |
Organization
Gifu University Hospital
Division name
Advanced Critical Care Center
Zip code
501-1194
Address
1-1 Yanagido, GIfu
TEL
0582306448
Homepage URL
edm2@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
Gifu University
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
The Medical Ethics Committee of the Gifu University Graduate School of Medicine
Address
1-1 Yanagido, GIfu
Tel
0582306059
rinri@gifu-u.ac.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
| 2023 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
150
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
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 06 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | 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 | 03 | Month | 23 | Day |
Last modified on
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057718
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