UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020262 |
|---|---|
| Receipt number | R000020067 |
| Scientific Title | Biomarker study of renal injury after transcatheter valvuloplasty |
| Date of disclosure of the study information | 2015/12/20 |
| Last modified on | 2025/07/11 08:47:25 |
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Basic information
Public title
Biomarker study of renal injury after transcatheter valvuloplasty
Acronym
Biomarker study of renal injury after transcatheter valvuloplasty
Scientific Title
Biomarker study of renal injury after transcatheter valvuloplasty
Scientific Title:Acronym
rBiomarker study of renal injury after transcatheter valvuloplasty
Region
| Japan |
Condition
Condition
valve disease(aorta, mitral)
Classification by specialty
| Cardiology | Nephrology | Vascular surgery |
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
perioperative AKI
Basic objectives2
Others
Basic objectives -Others
perioperative AKI
Trial characteristics_1
Others
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Perioperative renal impairment patients and urinary biomarker elevation rate
Key secondary outcomes
Correlation between kidney injury severity and biomarker elevation rate
Early diagnosis of AKI becomes possible using POCT
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
AKI
Key exclusion criteria
hemodyalisis
emergency ope
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yumi Obata |
Organization
St Marianna university school of medicine
Division name
Anesthesiology
Zip code
Address
Sugao2-16-1 Miyamae Kawasaki Kanagawa
TEL
0449778111
y2obata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumi Obata |
Organization
St Marianna university school of medicine
Division name
Anesthesiology
Zip code
Address
Sugao2-16-1 Miyamae Kawasaki Kanagawa
TEL
0449778111
Homepage URL
y2obata@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna university school of medicine
Institute
Department
Personal name
Funding Source
Organization
St Marianna university school of medicine
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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
1
Org. issuing International ID_1
1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 04 | Month | 30 | Day |
Other
Other related information
Change of urinary biomarker in perioperative acute kidney injury
Develop predictive models for AKI and AKD development
Management information
Registered date
| 2015 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020067
