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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026215
Receipt No. R000030117
Scientific Title Clinical usefulness of urinary liver-type fatty acid binding protein as a marker of chronic kidney disease in patients undergoing open abdominal aortic aneurysm repair
Date of disclosure of the study information 2019/02/20
Last modified on 2018/05/05

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Basic information
Public title Clinical usefulness of urinary liver-type fatty acid binding protein as a marker of chronic kidney disease in patients undergoing open abdominal aortic aneurysm repair
Acronym Clinical usefulness of a biomarker of chronic kidney disease in patients undergoing open abdominal aortic aneurysm repair
Scientific Title Clinical usefulness of urinary liver-type fatty acid binding protein as a marker of chronic kidney disease in patients undergoing open abdominal aortic aneurysm repair
Scientific Title:Acronym Clinical usefulness of a biomarker of chronic kidney disease in patients undergoing open abdominal aortic aneurysm repair
Region
Japan

Condition
Condition postoperative chronic kidney disease
Classification by specialty
Nephrology Vascular surgery Anesthesiology
Cardiovascular surgery Operative medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of usefulness of biomarkar for the prediction o fpostoperative CKD
Basic objectives2 Others
Basic objectives -Others observational
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes postoperative CKD
Key secondary outcomes

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 none
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YUmi Obata
Organization St Mariannna University School of Medicine
Division name Anesthesiology
Zip code
Address Sugao 2-16-1 Miyamae Kanagawa
TEL 044-977-8111
Email y2obata@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Obata
Organization St Mariannna University School of Medicine
Division name Anesthesiology
Zip code
Address Sugao 2-16-1 Miyamae Kanagawa
TEL 044-977-8111
Homepage URL
Email y2obata@marianna-u.ac.jp

Sponsor
Institute St Mariannna University School of Medicine
Institute
Department

Funding Source
Organization St Mariannna University School of Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2019 Year 02 Month 20 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
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
2016 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 10 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information From September 2011 to June 2015, we examined the blood collection results of patients who underwent abdominal aortic aneurysm replacement surgery until November 2016

Management information
Registered date
2017 Year 02 Month 19 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=R000030117

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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