UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017418 |
|---|---|
| Receipt number | R000020202 |
| Scientific Title | Is change in subcutaneous water amount of patients correlated with that in circulating blood volume? |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2016/03/12 21:58:18 |
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Basic information
Public title
Is change in subcutaneous water amount of patients correlated with that in circulating blood volume?
Acronym
Subcutaneous water amount and circulating blood volume
Scientific Title
Is change in subcutaneous water amount of patients correlated with that in circulating blood volume?
Scientific Title:Acronym
Subcutaneous water amount and circulating blood volume
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the relationship between change in subcutaneous water amount and that in circulating blood volume of patients with hemodialysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
relationship between change in subcutaneous water amount and that in circulating blood volume of patients after hemodialysis
Key secondary outcomes
relationship between change in subcutaneous water amount and that in body weight of patients.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients receiving hemodialysis 3 times/week
Key exclusion criteria
patients with hypoalbuminemia less than 1 g/dL
patients with unstable hemodynamics
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidetomo Niwa |
Organization
Hirosaki university graduate school of medicine
Division name
department of anesthesiology
Zip code
Address
Hirosaki city Zaifu-cho 5, Aomori
TEL
0172-39-5113
niwahide@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidetomo Niwa |
Organization
Hrosaki university graduate school of medicine
Division name
department of anesthesilogy
Zip code
Address
Hirosaki city, Zaifu-cho 5, Aomori
TEL
0172-39-5113
Homepage URL
niwahide@gmail.com
Sponsor or person
Institute
Hirosaki university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki university graduate school of medicine, department of anesthesiology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | Month | 11 | 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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
changes in sucutaneous water amount, circulating blood volume, and body weight after patients receive hemodialysis
Management information
Registered date
| 2015 | Year | 05 | Month | 05 | Day |
Last modified on
| 2016 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020202
