UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040846
Receipt number 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 2022/12/23 19:05:42

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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 or person

Institute

Kyushu University Hospital

Institute

Department

Personal name



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

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

128

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

Completed

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

2022 Year 06 Month 22 Day

Date analysis concluded

2022 Year 12 Month 31 Day


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

2022 Year 12 Month 23 Day



Link to view the page

Value
https://center6.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