UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the cardiovascular surgery
Acronym	Usefulness of creatinine reduction ratio.
Scientific Title	Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the cardiovascular surgery
Scientific Title:Acronym	Usefulness of creatinine reduction ratio.
Region	Japan

Condition
Condition	Cardiovascular surgical patient
Classification by specialty	Cardiovascular surgery Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Considered as an indicator of renal failure perioperative rate of change of the Cr value of preoperative and postoperative Cr value, to evaluate the usefulness as a predictor of AKI development.
Basic objectives2	Others
Basic objectives -Others	I diagnosed with acute kidney injury patients with creatinine rose to 1.5-fold increase or 0.3mg/dl or more than the reference value within 48 hours after surgery. Consider about what to make earlier prediction of renal injury by making a correction of creatinine and creatinine moisture balance rate of change, weight change, due to changes in urea nitrogen.
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation for usefulness as a predictor of AKI creatinine value rate of change. Create the Area Under the Curve, to determine the reliability of the predictor.
Key secondary outcomes	By correcting the Cr value using fluid balance, weight change, urea nitrogen value of the immediate post-operative (BUN), it should be considered the possibility of early diagnosis of AKI.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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Purpose of intervention
Type of intervention
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Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	I include patients who were performed operation as cardiac surgery with cardiopulmonary bypass.
Key exclusion criteria	Patients under 18 years old are excluded.
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shunsuke Takaki
Organization	Yokohama City University Hospital
Division name	Intensive Care Unit
Zip code
Address	3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL	0457872800
Email	shunty5323@gmail.com

Public contact
Name of contact person	1st name Middle name Last name Shunsuke Takaki
Organization	Yokohama City University Hospital
Division name	Intensive Care Unit
Zip code
Address	3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan
TEL	0457872800
Homepage URL
Email	shunty5323@gmail.com

Sponsor
Institute	Yokohama City University Hospital Department of Anesthesiology
Institute
Department

Funding Source
Organization	Yokohama City University Hospital Department of Anesthesiology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
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IRB Contact (For public release)
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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	横浜市立大学附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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
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Results Delayed
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Baseline Characteristics
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IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 10 Day
Last follow-up date	2015 Year 12 Month 20 Day
Date of closure to data entry	2015 Year 12 Month 20 Day
Date trial data considered complete	2015 Year 12 Month 25 Day
Date analysis concluded	2015 Year 12 Month 30 Day

Other
Other related information	No patients were collected.

Management information
Registered date	2013 Year 10 Month 01 Day
Last modified on	2016 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013925

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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