UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017413
Receipt number 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 21:17:37

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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