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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004857
Receipt No. R000005491
Scientific Title Prospective observational study on clinical effect of hemodialysis using electrolyzed water
Date of disclosure of the study information 2011/01/11
Last modified on 2017/07/26

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Basic information
Public title Prospective observational study on clinical effect of hemodialysis using electrolyzed water
Acronym Clinical effect of hemodialysis by electrolyzed water
Scientific Title Prospective observational study on clinical effect of hemodialysis using electrolyzed water
Scientific Title:Acronym Clinical effect of hemodialysis by electrolyzed water
Region
Japan

Condition
Condition Patients on chronic hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The number of dialysis patients in Japan has exceeded more than 290 thousand at the end of 2009. While the patients prognosis has remained poor, with annual mortality 7 to 8%. Accumulating evidences have shown that apparatus of dialysis and impure water for dialysis have contributed to the development of chronic inflammation and enhanced oxidative stress, which are commonly observed in dialysis patients, and they are supposed to play a central role for excess death of dialysis patients. The present research group (Tohoku University and Nihon Trim Co.) developed a novel dialysis system employing water electrolysis, which renders anti-oxidative and inflammatory effects. The system is commercially available, and it has been distributed in Japan.
The present prospective observational study aims to examine the clinical effect of the system on the long-term outcomes of patients, as compared with the conventional system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Primary endpoints: all-cause of mortality and morbidities during the study period such as cardiac events (congestive heart failure, acute cardiac infarction, angina pectoris), stroke, infectious disease, and leg amputation due to arteriosclerosis obliterans
Key secondary outcomes Secondary endpoints: the number of admissions, subjective assessments on general fatigue by dialysis, and blood parameters (hemoglobin, albumin, CRP)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Electrolyzed water hemodialysis group: hemodialysis (HD) treatment applying electrolyzed water for HD solution, HD performance; three times a week for 4-5 hours each session (Dialysate flow 500 ml/min), for up to 60 months.
Interventions/Control_2 Control hemodialysis group: HD treatment applying standard water for HD solution; HD performance , three times a week, 4-5 hours session each (dialysate flow; 500 ml/min), for
up to 60 months.
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 who are on hemodialysis using water electrolysis system, and those who are on conventional standard system as control, are selected. The control patients need to be matched to the patients on water electrolysis system.
Key exclusion criteria The following cases are not included in the study; critically ill patients due to malignant disease or other comorbidities, under 20 years old, those who cannot give consent by their selves.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Nakayama
Organization 1)Tohoku University United Centers for Advanced Research and Translational Medicine Center for Advanced and Integrated Renal Science 2)Fukushima University School of Medicine
Division name 2)Department of Nephrology, Hypertension, Diabetology, Endocrinology, and Metabolism
Zip code
Address 1)1-1 Seiryo-cho, Aoba-ku, Sendai,Miyagi,980-8574, Japan 2)1 Hikarigaoka, Fukushima City, Fukushima, 960-1295 Japan
TEL 022-717-7393
Email masaaki.nakayama.c1@tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Kabayama
Organization Japanese society for EW-HD
Division name Study secretariat of EW-HD
Zip code
Address 22nd Floor, Herbis Ent Office Tower, 2-2-22 Umeda Kita-ku, Osaka, 530-0001, Japan
TEL 06-6456-4633
Homepage URL
Email info@ew-hd.org

Sponsor
Institute TOHOKU University
Institute
Department

Funding Source
Organization NIHON TRIM CO., LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 01 Month 11 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
Results
During the 3.28-year mean observation period, there were no differences in dialysis parameters between the two groups; however, post-dialysis hypertension was ameliorated with significant reductions in anti-hypertensive agents in the E-HD patients. 
Multivariate analysis of the Cox proportional hazards model revealed E-HD as an independent significant factor for the primary endpoint after adjusting for confounding factors. HD applying an H2-dissolved HD solution could improve the prognosis of chronic HD patients.
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
2010 Year 06 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2016 Year 12 Month 31 Day
Date of closure to data entry
2016 Year 12 Month 31 Day
Date trial data considered complete
2016 Year 12 Month 31 Day
Date analysis concluded
2017 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 11 Day
Last modified on
2017 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005491

Research Plan
Registered date File name
2017/07/26 Supplementary study protocol.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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