UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033053 |
|---|---|
| Receipt number | R000037688 |
| Scientific Title | Electrolyte fluctuation due to bulk replacement before and after Hemodiafilter |
| Date of disclosure of the study information | 2018/06/21 |
| Last modified on | 2018/11/19 11:47:52 |
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Basic information
Public title
Electrolyte fluctuation due to bulk replacement before and after Hemodiafilter
Acronym
Electrolyte fluctuation due to bulk replacement before and after Hemodiafilter
Scientific Title
Electrolyte fluctuation due to bulk replacement before and after Hemodiafilter
Scientific Title:Acronym
Electrolyte fluctuation due to bulk replacement before and after Hemodiafilter
Region
| Japan |
Condition
Condition
Dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Under online HDF enforcement, we evaluate how ionized Mg and ionized Ca fluctuate before and after Hemodiafilter.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ionized Mg, ionized Ca
Key secondary outcomes
Na, K, Cl, pH, bicarbonate ion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Change the dialysis condition in the order of HD, Pre-OHDF (replacement amount: 84 L), Post-OHDF (replacement amount: 16 L), IHDF.Each time dialysis conditions are changed. The intervention period is two weeks.
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
Patients with corrected total Ca within the reference value (8.4 to 10.0 mg / dL)
Patients with serum Mg within the reference value (1.8 to 2.4 mg / dL)
Stable maintenance dialysis patients undergoing OHDF
Patients who do not change the dose of Cinacalcet hydrochloride during the study
Patients who can obtain consent from the patients themselves or their agents
Key exclusion criteria
Have severe cardiovascular complications.
Severe liver dysfunction, respiratory failure.
When the dose of Cinacalcet hydrochloride is changed during the evaluation period.
Other cases when the doctor considers it unsuitable for participation in this research.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tanaka Yusaku |
Organization
Kawashima Hospital
Division name
Clinical Engineering
Zip code
Address
Tokushima Prefecture Tokushima City Kitasako Ichibancho 1-39
TEL
088-631-0110
yu-0724@khg.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tanaka Yusaku |
Organization
Kawashima Hospital
Division name
Clinical Engineering
Zip code
Address
Tokushima Prefecture Tokushima City Kitasako Ichibancho 1-39
TEL
088-631-0110
Homepage URL
yu-0724@khg.or.jp
Sponsor or person
Institute
Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
Kawashima 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
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
| 2018 | Year | 06 | Month | 21 | 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
| 2018 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037688
