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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000017413
Receipt No. R000020197
Scientific Title Investigation of the risk factors of acute kidney injury after aortic endovascular repair and its effect on mortality and morbidity.
Date of disclosure of the study information 2015/05/15
Last modified on 2021/06/04

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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

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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