UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014367 |
|---|---|
| Receipt number | R000016712 |
| Scientific Title | Comparison of bicarbonate concentration between arterial and venous blood. |
| Date of disclosure of the study information | 2014/06/28 |
| Last modified on | 2021/06/29 13:08:15 |
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Basic information
Public title
Comparison of bicarbonate concentration between arterial and venous blood.
Acronym
Comparison of bicarbonate concentration between arterial and venous blood.
Scientific Title
Comparison of bicarbonate concentration between arterial and venous blood.
Scientific Title:Acronym
Comparison of bicarbonate concentration between arterial and venous blood.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the usefulness of venous bicarbonate concentration for treetment of CKD patient.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HCO3-
pH, PaCO2, PaO2, BE
Key secondary outcomes
BUN, Cr, eGFR, Cystatin-C, Albumin, electrolyte
Body height, body weight,
albuminuria (proteinuria)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with CKD
Key exclusion criteria
Patients who attending physician deem unsuitable for this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Kihara |
Organization
Juntendo University Faculty of Medicine, Juntendo hospital
Division name
Division of Nephrology
Zip code
1138431
Address
3-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358021065
masao-k@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Kihara |
Organization
Juntendo University Faculty of Medicine, Juntendo hospital
Division name
Division of Nephrology
Zip code
113-8431
Address
3-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
0358021065
Homepage URL
masao-k@juntendo.ac.jp
Sponsor or person
Institute
Division of Nephrology, Department of Internal Medicine, Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Juntendo Uuniversity
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-5802-1584
hmasuko@juntendo.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
順天堂大学医学部附属順天堂医院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 28 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 31 | Day |
Other
Other related information
This study is polot study for future trial.
Management information
Registered date
| 2014 | Year | 06 | Month | 24 | Day |
Last modified on
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016712
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
