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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009287
Receipt No. R000010906
Scientific Title Acid-base status and chronic kidney disease-mineral and bone disorder in hemodialysis patients: Results from the nationwide registry of the Japanese Society for Dialysis Therapy
Date of disclosure of the study information 2012/11/08
Last modified on 2017/05/15

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Basic information
Public title Acid-base status and chronic kidney disease-mineral and bone disorder in hemodialysis patients: Results from the nationwide registry of the Japanese Society for Dialysis Therapy
Acronym Acid-base status and chronic kidney disease-mineral and bone disorder
Scientific Title Acid-base status and chronic kidney disease-mineral and bone disorder in hemodialysis patients: Results from the nationwide registry of the Japanese Society for Dialysis Therapy
Scientific Title:Acronym Acid-base status and chronic kidney disease-mineral and bone disorder
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Metabolic acidosis in hemodialysis patients is one of important factors for chronic kidney disease-mineral and bone disorder (CKD-MBD). Little attention has been given to the influence of acid-base status on CKD-MBD. In worldwide guidelines (DOPPS in 2004, EBPG in 2007, and UKRAG in 2009), pre-dialysis bicarbonate level for hemodialysis patients was recommended to maintain 18-24 mEq/L from a prognostic viewpoint, while K/DOQI guidelines in 2003 yielded conflicting results (more than 22 mEq/L) from a viewpoint of bone metabolism and disease. The discrepancy is due to the fact that post-dialysis overalkalization develops in such situation of more than 22 mEq/L of pre-dialysis bicarbonate level, and leads to precipitate metastatic calcification and cardiovascular death.
The goal of this study is to clarify the optimal correction of metabolic acidosis for preventing cardiovascular event and death.
Basic objectives2 Others
Basic objectives -Others Cross-sectional study is made of hemodialysis patients who received hemodialysis at least 1 year and 3 times a week. Data are obtained from the nationwide registry of the Japanese Society for Dialysis Therapy (2008-2009), including 52,432 HD patients. The relationship between pre-dialysis acid-base status (bicarbonate and pH level) and patient information (patients background, dialysis dose, nutritional factor, clinical data and using dialysate) is analyzed, and cardiovascular mortality and event of myocardial infarction are followed during 1 year.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Myocardial infarction
Death
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Hemodialysis patients who received hemodialysis at least 1 year and 3 times a week.
Key exclusion criteria None.
Target sample size 52432

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadashi Yamamoto
Organization Shirasagi Hospital
Division name Research Division
Zip code
Address 7-11-23 Kumata, Higashisumiyoshi, Osaka 546-0002, Japan
TEL 06-6714-1661
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadashi Yamamoto
Organization Shirasagi Hospital
Division name Research Division
Zip code
Address 7-11-23 Kumata, Higashisumiyoshi, Osaka 546-0002, Japan
TEL 06-6714-1661
Homepage URL http://www.shirasagi-hp.or.jp/
Email yamamoto@shirasagi-hp.or.jp

Sponsor
Institute Shirasagi Hospital
Institute
Department

Funding Source
Organization Shirasagi Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 JRDR10001
Org. issuing International ID_1 Japanese Society for Dialysis Therapy
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 白鷺病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 08 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://dx.doi.org/10.1053/j.ajkd.2015.04.014
Number of participants that the trial has enrolled
Results
Of 15,132 patients, during follow-up, 1,042 died of all causes, including 408 CV deaths. In the adjusted analysis for all-cause mortality, HRs compared to the reference group were significantly higher in patients with predialysis pH>7.40 (HR, 1.36; 95% CI, 1.13-1.65) and postdialysis pH<7.40 (HR, 1.22;95% CI, 1.00-1.49). Predialysis pH>7.40 was also associated with higher risk of CV mortality (HR, 1.34;95% CI, 1.01-1.79). No association of pre- or postdialysis bicarbonate level with all-cause and CV mortality was observed. Predialysis pH may be the most appropriate reference for accurate correction of metabolic acidosis in dialysis 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
2012 Year 04 Month 03 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 08 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional observational study from the database of the nationwide registry of the Japanese Society for Dialysis Therapy in 2008-2009.

Management information
Registered date
2012 Year 11 Month 08 Day
Last modified on
2017 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010906

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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