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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017492
Receipt No. R000020274
Scientific Title postoperative CKD study of trans-catheter valve repair
Date of disclosure of the study information 2015/06/01
Last modified on 2018/05/05

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Basic information
Public title postoperative CKD study of trans-catheter valve repair
Acronym postoperative CKD study of trans-catheter valve repair
Scientific Title postoperative CKD study of trans-catheter valve repair
Scientific Title:Acronym postoperative CKD study of trans-catheter valve repair
Region
Japan

Condition
Condition valve disease
Classification by specialty
Cardiology Vascular surgery Anesthesiology
Cardiovascular surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of perioperative AKI and risk factor of CKD
Basic objectives2 Others
Basic objectives -Others observational
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes perioperative AKI and risk factor of CKD
Key secondary outcomes Investigation of risk factor of perioperative AKI and CKD

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 none
Key exclusion criteria hemodialysis patients
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name TakeshiTateda
Organization St Marianna university school of Medicine
Division name Anesthesiaogy
Zip code
Address Sugao 2-16-1 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 Anesthesiaogy
Zip code
Address Sugao 2-16-1 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 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
2015 Year 06 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 Open public recruiting
Date of protocol fixation
2015 Year 05 Month 06 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded
2021 Year 03 Month 31 Day

Other
Other related information perioperative AKI

Management information
Registered date
2015 Year 05 Month 11 Day
Last modified on
2018 Year 05 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020274

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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