UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the risk factors of acute kidney injury after aortic endovascular repair and its effect on mortality and morbidity.
Acronym	Investigation of the risk factors of acute kidney injury after aortic endovascular repair its effect on mortality and morbidity.
Scientific Title	Investigation of the risk factors of acute kidney injury after aortic endovascular repair and its effect on mortality and morbidity.
Scientific Title:Acronym	Investigation of the risk factors of acute kidney injury after aortic endovascular repair its effect on mortality and morbidity.
Region	Japan

Condition
Condition	Abdominal aortic aneurysm.
Classification by specialty	Vascular surgery Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We seek the risk factors of postoperative AKI after EVAR. Moreover, we seek to determine if AKI was associated with an increase in all-cause mortality and incidence of postoperative permanent dialysis therapy among patients undergone EVAR.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	All-cause mortality and incidence of postoperative permanent dialysis therapy among patients undergone EVAR.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with thoracic or abdominal aortic aneurysm who underwent EVAR between 2010 and 2015 in Gifu University Hospital and Gifu prefectural general medical center.
Key exclusion criteria	Patients who received permanent dialysis therapy preoperatively.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Kimito Middle name Last name Minami
Organization	Gifu University Graduate School of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code	XXXXXX
Address	Yanagido 1-1, Gifu, Japan
TEL	+81-58-230-6404
Email	nann_5115@ybb.ne.jp

Public contact
Name of contact person	1st name Kimito Middle name Last name Minami
Organization	Gifu University Graduate School of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code	XXXXXXX
Address	Yanagido 1-1, Gifu, Japan
TEL	+81-58-230-6404
Homepage URL
Email	nann_5115@ybb.ne.jp

Sponsor
Institute	Gifu University Graduate School of Medicine, Department of Anesthesiology and Pain Medicine
Institute
Department

Funding Source
Organization	Gifu University Graduate School of Medicine, Department of Anesthesiology and Pain Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Gifu University Graduate School of Medicine
Address	Yanagido 1-1, Gifu, Japan
Tel	+81-58-230-6059
Email	gjme00004@jim.gifu-u.ac.jp

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	岐阜大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2015 Year 05 Month 15 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007%2Fs00540-017-2380-9
Publication of results	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007%2Fs00540-017-2380-9
Number of participants that the trial has enrolled	490
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	Main results already published
Date of protocol fixation	2015 Year 12 Month 01 Day
Date of IRB	2015 Year 12 Month 01 Day
Anticipated trial start date	2015 Year 12 Month 15 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 05 Month 12 Day

Other

Other related information

The following characteristics are collected from clinical records; age, sex, height, body weight, preoperative sCr, preoperative eGFR, preoperative serum total bilirubin, coexisting hypertension, coexisting diabetes, coexisting chronic heart failure, coexisting chronic obstructive pulmonary disease, coexisting peripheral vascular disease, preoperative use of beta-blocker, preoperative use of angiotensin-converting enzyme inhibitor, preoperative use of angiotensin receptor blocker, emergency surgery, classification of American Society of Anesthesiologists, surgical duration, anesthetic duration, intraoperative amount of contrast administered, intraoperative amount of transfusion, intraoperative amount of fluid administered, and intraoperative amount of hydroxyethyl starch administered. We seek the risk factors of AKI using Cox multivariable regression analysis.

Management information
Registered date	2015 Year 05 Month 04 Day
Last modified on	2021 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020197