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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014588
Receipt No. R000016973
Scientific Title Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the thoracic and abdominal surgery
Date of disclosure of the study information 2014/07/18
Last modified on 2015/08/20

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

Condition
Condition Open heart surgery
Classification by specialty
Surgery in general
Classification by malignancy Others
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
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 I include patients who were performed operation as thoracic or abdominal surgery (liver resection, pancreaticoduodenectomy, and esophageal cancer resection).
Key exclusion criteria Patients under 18 years old are excluded.
Target sample size 400

Research contact person
Last 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
1st name of contact person
1st name
Middle name
Last name Shunsuke Takakii
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
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 07 Month 18 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
Patients who developed AKI were very small sample size, so protocol required to improve.
Therefore, this current research was ceased.
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 Terminated
Date of protocol fixation
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Whether creatinine reduction ratio associated kidney injury.

Management information
Registered date
2014 Year 07 Month 18 Day
Last modified on
2015 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016973

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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