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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020262
Receipt No. R000020067
Scientific Title perioperative AKI of trans catheter valve repair
Date of disclosure of the study information 2015/12/20
Last modified on 2019/11/10

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Basic information
Public title perioperative AKI of trans catheter valve repair
Acronym perioperative AKI of trans catheter valve repair
Scientific Title perioperative AKI of trans catheter valve repair
Scientific Title:Acronym perioperative AKI of trans catheter valve repair
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

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
Email 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
Email y2obata@marianna-u.ac.jp

Sponsor
Institute St Marianna university school of medicine
Institute
Department

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
Email

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
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

Management information
Registered date
2015 Year 12 Month 18 Day
Last modified on
2019 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020067

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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