UMIN-CTR Clinical Trial

Basic information
Public title	Examination of predictors of acute kidney injury after cardiothoracic surgery
Acronym	Prediction of acute kidney injury after cardiothoracic surgery
Scientific Title	Examination of predictors of acute kidney injury after cardiothoracic surgery
Scientific Title:Acronym	Prediction of acute kidney injury after cardiothoracic surgery
Region	Japan

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

Objectives
Narrative objectives1	Search factors that can predict acute kidney injury among factors immediately after surgery
Basic objectives2	Others
Basic objectives -Others	Examination of predictors of acute kidney injury among factors immediately after surgery (creatinine value, vital, catecholamine amount, etc.)
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Acute kidney injury within 7 days after surgery
Key secondary outcomes	In-hospital death Acute kidney injury within 48 hours after surgery

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 undergoing cardiovascular surgery
Key exclusion criteria	Dialysis patients Non cardiothoracic surgery Reoperation during the same hospitalization
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Hideaki Middle name Last name Oka
Organization	Matsuyama redcross hospital
Division name	Division of Kidney Center
Zip code	790-8524
Address	1 Bunkyocho, Matsuyama City, Ehime 790-8524, Japan
TEL	089-924-1111
Email	okanokao@matsuyama.jrc.or.jp

Public contact
Name of contact person	1st name Hideaki Middle name Last name Oka
Organization	Matsuyama redcross hospital
Division name	Division of Kidney Center
Zip code	790-8524
Address	1 Bunkyocho, Matsuyama City, Ehime 790-8524, Japan
TEL	089-924-1111
Homepage URL
Email	okanokao@matsuyama.jrc.or.jp

Sponsor
Institute	Division of Kidney Center, Matsuyama redcross hospital
Institute
Department

Funding Source
Organization	Division of Kidney Center, Matsuyama redcross hospital
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	Matsuyama redcross hospital
Address	1 Bunkyocho, Matsuyama City, Ehime
Tel	089-924-1111
Email	okanokao@matsuyama.jrc.or.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	2017 Year 01 Month 30 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	No longer recruiting
Date of protocol fixation	2013 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 01 Month 01 Day
Last follow-up date	2017 Year 01 Month 30 Day
Date of closure to data entry	2017 Year 04 Month 30 Day
Date trial data considered complete	2017 Year 04 Month 30 Day
Date analysis concluded	2017 Year 06 Month 30 Day

Other
Other related information	Retrospective cohort study

Management information
Registered date	2017 Year 01 Month 28 Day
Last modified on	2019 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029764