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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040846
Receipt No. R000046637
Scientific Title A cross-sectional study to develop a new equation to estimate blood ionized calcium level in hemodialysis patients
Date of disclosure of the study information 2020/08/01
Last modified on 2020/10/27

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Basic information
Public title A cross-sectional study to develop a new equation to estimate blood ionized calcium level in hemodialysis patients
Acronym A cross-sectional study to develop a new equation to estimate blood ionized calcium level in hemodialysis patients
Scientific Title A cross-sectional study to develop a new equation to estimate blood ionized calcium level in hemodialysis patients
Scientific Title:Acronym A cross-sectional study to develop a new equation to estimate blood ionized calcium level in hemodialysis patients
Region
Japan

Condition
Condition End-stage kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To develop a new equation to estimate blood ionized calcium level by serum total calcium and other serum biochemical paramters
Basic objectives2 Others
Basic objectives -Others To determine the validity of the previously reported equation to estimate blood ionized calcium level by serum total calcium level and other biochemical paraters
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Blood ionized calcium
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients who received blood gas analysis and serum biochemical test using the same blood sample
Key exclusion criteria Critically ill patiens who needed treatment in the intensive care unit
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Takanari
Middle name
Last name Kitazono
Organization Kyushu University Hospital
Division name Department of Nephrology, Hypertension, and Strokology
Zip code 812-8582
Address Maidasih 3-1-1, Higashi-Ku, Fukuoka
TEL 092-642-5256
Email kitazono@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Shunsuke
Middle name
Last name Yamada
Organization Kyushu University Hospital
Division name Department of Nephrology, Hypertension, and Strokology
Zip code 812-8582
Address Maidasih 3-1-1, Higashi-Ku, Fukuoka
TEL 092-642-5843
Homepage URL http://www.kcu.med.kyushu-u.ac.jp/
Email yamada.shunsuke.944@m.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Hospital
Institute
Department

Funding Source
Organization Kyushu University 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 Kyushu University Hospital
Address Maidasih 3-1-1, Higashi-Ku, Fukuoka
Tel 092-642-5082
Email byskenkyu@jimu.kyushu-u.ac.jp

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
2020 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Enrolling by invitation
Date of protocol fixation
2020 Year 07 Month 31 Day
Date of IRB
2020 Year 10 Month 05 Day
Anticipated trial start date
2020 Year 10 Month 27 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Among patients who initiated hemodialysis therapy or who was hospitalized for the treatment related to hemodialysis at Kyushu University, those who received blood gas analsys and serum biochemical test using the same blood sample were recruited. A new equation was developed to estimate blood ionized calcium level by serum biochemical paramters such as serum levels of total calcium, sodium, chloride, phosphate, and bicarbonate. For the creation of a new equation, we ued multivriable-adjusted linear regression models. We also compared the accuracy of estimating blood ionized calcium level among previously reported equations using serum albumin level.

Management information
Registered date
2020 Year 06 Month 21 Day
Last modified on
2020 Year 10 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046637

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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