UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011765 |
|---|---|
| Receipt number | R000013757 |
| Scientific Title | Study of the clinical effects by the central supply method of the acetic acid-free dialytic fluid |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2013/09/14 12:55:31 |
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Basic information
Public title
Study of the clinical effects by the central supply method of the acetic acid-free dialytic fluid
Acronym
clinical effects of the acetic acid-free dialytic fluid
Scientific Title
Study of the clinical effects by the central supply method of the acetic acid-free dialytic fluid
Scientific Title:Acronym
clinical effects of the acetic acid-free dialytic fluid
Region
| Japan |
Condition
Condition
end-stage renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In 2007, first acetic acid-free dialytic fluid (car placard) was released in a country. The car placard has a metabolic acidotic superior correction effect, and the dialysis that National Kidney Foundation-Kidney Disease Outcomes Quality Initiative (K/DOQI) guideline "which the HCO3 density should maintain in blood before dialysis of the hemodialysis patient than 22 mEq/L" recommends is possible. We examine an effect to give a clinical response of acetic acid dialytic fluid and the acetic acid-free dialytic fluid in the central supply method and antioxidant ability.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
For a hemodialysis patient, we examine a 12-month clinical response of acetic acid-free dialytic fluid after use in acetic acid dialytic fluid for six months. Examination item are dialysis efficiency (Kt/V), a circulation change (mean blood pressure and the pulse), nourishment dialyzing are in a state (serum protein and albumin, nPCR), acidotic improvement effect (pH, HCO3-, BE).
Key secondary outcomes
For a hemodialysis patient, we measure a 12-month oxidation stress marker of acetic acid-free dialytic fluid after use in acetic acid dialytic fluid for six months. Examination item are blood reduced glutathione/oxidized glutathione ratio and serum MDA-LDL.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
six months of Acetic acid component dialytic fluid use, and then 12 months of acetic acid-free dialytic fluid use
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
end-stage renal failure patients with stable outpatient maintenance hemodialysis 20 years or older
Key exclusion criteria
hemodialysis patients without any cancer or acute Inflammation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Tsuji |
Organization
National Defense Medical College Hospital
Division name
Department of Blood Purification
Zip code
Address
3-2 Namiki, Tokorozawa Saitma, Japan
TEL
04-2995-1511
futebol@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Ishizeki |
Organization
National Defense Medical College Hospital
Division name
Department of Blood Purification
Zip code
Address
3-2 Namiki, Tokorozawa Saitma, Japan
TEL
04-2995-1511
Homepage URL
halfmoon@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
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
防衛医科大学校病院（埼玉県） National Defense Medical College Hospital (Saitama)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
58th Congress of the Japanese Society for Dialysis therapy
Acetic acid-free dialytic fluid accepted meaningful improvement of acidotic revision, a nourishment state and anemia. By the long usage of the acetic acid-free dialytic fluid, blood GSH/GSSG was improved significantly, and plasma homocysteine significantly decreased. Thus, an effect to prevent the serious complications in the chronic hemodialysis patient is expected.
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 | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 03 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 25 | Day |
Date trial data considered complete
| 2012 | Year | 08 | Month | 05 | Day |
Date analysis concluded
| 2012 | Year | 10 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 14 | Day |
Last modified on
| 2013 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013757
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