UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Electrolyte fluctuation due to bulk replacement before and after Hemodiafilter
Title of the study (Brief title)	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	Tanaka Yusaku
Organization	Kawashima Hospital
Division name	Clinical Engineering
Address	Tokushima Prefecture Tokushima City Kitasako Ichibancho 1-39
TEL	088-631-0110
Email	yu-0724@khg.or.jp

Public contact
Name of contact person	Tanaka Yusaku
Organization	Kawashima Hospital
Division name	Clinical Engineering
Address	Tokushima Prefecture Tokushima City Kitasako Ichibancho 1-39
TEL	088-631-0110
Homepage URL
Email	yu-0724@khg.or.jp

Sponsor
Institute	Kawashima Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037688