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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037141
Receipt No. R000042312
Scientific Title Retrospective Cohort Study on post-operative acute kidney injury in non-cardiac surgery
Date of disclosure of the study information 2019/06/24
Last modified on 2019/06/23

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Basic information
Public title Retrospective Cohort Study on post-operative acute kidney injury in non-cardiac surgery
Acronym NARA-AKI Cohort Study
Scientific Title Retrospective Cohort Study on post-operative acute kidney injury in non-cardiac surgery
Scientific Title:Acronym NARA-AKI Cohort Study
Region
Japan

Condition
Condition Acute kidney injury
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate predictors of post-operative acute kidney injury and predictors of prognosis of post-operative acute kidney injury
Basic objectives2 Others
Basic objectives -Others To investigate predictors of post-operative acute kidney injury from following variables: pre-operative characteristics (age, sex, comorbidities, use of medications), intra-operative factors (fluid balance, transfusion, use of medication, blood pressure, the amount of bleeding). Also, to investigate predictors of long-term prognosis after post-operative acute kidney injury.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes post-operative acute kidney injury, long-term outcomes (death, cardiovascular events, infection requiring hospitalization, development of malignancy)
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 Adults (age>=18) who underwent non-cardiac surgery under general anesthesia from April 1, 2007 to December 31, 2014.
Key exclusion criteria Urologic surgery, obstetric surgery, missing creatinine value peri-operatively, pre-operative dialysis
Target sample size 10000

Research contact person
Name of lead principal investigator
1st name Miho
Middle name
Last name Tagawa
Organization Nara Medical University
Division name Department of Nephrology
Zip code 6348521
Address 840 Shijo-cho, Kashihara-shi, Nara, 6348521, Japan
TEL 0744298865
Email tagawam@naramed-u.ac.jp

Public contact
Name of contact person
1st name Miho
Middle name
Last name Tagawa
Organization Nara Medical University
Division name Department of Nephrology
Zip code 6348521
Address 840 Shijo-cho, Kashihara-shi, Nara, 6348521, Japan
TEL 0744298865
Homepage URL
Email tagawam@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical Univerisity
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 Nara Medical University Ethics Committee
Address 840 Shijo-cho, Kashihara-shi, Nara, 6348521, Japan
Tel 0744-22-3051
Email f-okumura@naramed-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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 12 Month 28 Day
Date of IRB
2017 Year 03 Month 29 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is an observational study. The data is being collected currently.

Management information
Registered date
2019 Year 06 Month 23 Day
Last modified on
2019 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042312

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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