UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028422 |
|---|---|
| Receipt number | R000032529 |
| Scientific Title | Intradialysis body fluid change |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2022/08/01 11:23:18 |
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Basic information
Public title
Intradialysis body fluid change
Acronym
HD-BFC
Scientific Title
Intradialysis body fluid change
Scientific Title:Acronym
HD-BFC
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identify indicators of intradialysis body fluid change
Basic objectives2
Others
Basic objectives -Others
Indicators for hypovolemia
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hypotensive episode during dialysis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
different modality for blood purification
Interventions/Control_2
one session per each modality
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients under maintenance hemodialysis
Key exclusion criteria
Unstable hemodynamics during hemodilalysis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Tanemoto |
Organization
Shin-kuki General hospital
Division name
Internal medicine
Zip code
346-8530
Address
Kamihayami 418-1, Kuki, Saitama
TEL
81-480-26-0033
mtanemoto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Takabayashi |
Organization
Shin-kuki General hospital
Division name
General affairs
Zip code
346-8530
Address
Kamihayami 418-1, Kuki, Saitama
TEL
81-480-26-0033
Homepage URL
takabayashi@shinkuki-hp.jp
Sponsor or person
Institute
Shin-kuki General hospital
Institute
Department
Personal name
Funding Source
Organization
Shin-kuki General hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shin Kuki General Hospital
Address
Kamihayami 418-1, Kuki
Tel
81-480-26-0033
takabayashi@shinkuki-hp.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
新久喜総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Under analysis
Publication of results
Unpublished
Result
URL related to results and publications
Under analysis
Number of participants that the trial has enrolled
76
Results
Under analysis
Results date posted
| 2022 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
maintenance HD
Participant flow
maintenance HD
Adverse events
None
Outcome measures
Blood pressure
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 28 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032529
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
