UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	YUmi Obata
Organization	St Mariannna University School of Medicine
Division name	Anesthesiology
Address	Sugao 2-16-1 Miyamae Kanagawa
TEL	044-977-8111
Email	y2obata@marianna-u.ac.jp

Public contact
Name of contact person	Yumi Obata
Organization	St Mariannna University School of Medicine
Division name	Anesthesiology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 10 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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