UMIN-CTR Clinical Trial

Basic information
Public title	Development and Accuracy of a Prediction Model for Acute Kidney Injury in Postoperative Cardiovascular Surgery Patients
Acronym	Development of a Prediction Model for Acute Kidney Injury in postoperative Cardiovascular Surgery patients
Scientific Title	Development and Accuracy of a Prediction Model for Acute Kidney Injury in Postoperative Cardiovascular Surgery Patients
Scientific Title:Acronym	Development of a Prediction Model for Acute Kidney Injury in postoperative Cardiovascular Surgery patients
Region	Japan

Condition
Condition	Postoperative cardiovascular surgery patients
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To construct a model for predicting the development of acute kidney injury and to examine its accuracy in patients after cardiovascular surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Predictive ability of AKI outbreak prediction model (area under the curve of ROC)
Key secondary outcomes	To Identify the factors contributing to the predictive performance of AKI development

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who were undergone elective cardiovascular operation, and who were used cardiopulmonary bypass intraoperatively.
Key exclusion criteria	Patients without measuring Creatinine before ICU admission, whose eGFRs are under 45 before ICU admission, who have already been introduced to maintenance dialysis before ICU admission, and who discharged ICU by 6:00 a.m. the next morning.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shunsuke Middle name Last name Takaki
Organization	Yokohama City University Hospital
Division name	Intensive care unit
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL	045-787-2800
Email	shun5323@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Yusaku Middle name Last name Terada
Organization	Yokohama City University Hospital
Division name	Intensive care unit
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL	045-787-2800
Homepage URL
Email	y.terada1991@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Yokohama City University Ethics Review Board
Address	Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa prefecture
Tel	045-370-7627
Email	rinri@yokohama-cu.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	2022 Year 01 Month 03 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	Preinitiation
Date of protocol fixation	2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2017 Year 08 Month 01 Day
Last follow-up date	2021 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The target population for analysis is set according to the selection and exclusion criteria among the registered subjects. Based on functional data analysis, we will construct a model that dynamically predicts the risk of AKI in each patient using all vital sign data, patient background, and blood test data observed every minute. We will identify risk factors that contribute to the predictive performance of the model and evaluate the predictive ability of the model by the area under the curve of the ROC curve.

Management information
Registered date	2022 Year 01 Month 03 Day
Last modified on	2022 Year 01 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053044