UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046526 |
|---|---|
| Receipt number | R000053044 |
| Scientific Title | Development and Accuracy of a Prediction Model for Acute Kidney Injury in Postoperative Cardiovascular Surgery Patients |
| Date of disclosure of the study information | 2022/01/03 |
| Last modified on | 2022/01/03 21:14:08 |
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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
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
y.terada1991@gmail.com
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053044
