UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004857 |
|---|---|
| Receipt number | 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 13:26:34 |
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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
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
info@ew-hd.org
Sponsor or person
Institute
TOHOKU University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
