UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049390 |
|---|---|
| Receipt number | R000056121 |
| Scientific Title | Development of Machine Learning Models to Predict Delirium After On-Pump Cardiac Surgery Based on Preoperative and Intraoperative Indices |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2022/10/25 16:07:26 |
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Basic information
Public title
Development of Machine Learning Models to Predict Delirium After On-Pump Cardiac Surgery Based on Preoperative and Intraoperative Indices
Acronym
Development of Machine Learning Models to Predict Delirium After On-Pump Cardiac Surgery Based on Preoperative and Intraoperative Indices
Scientific Title
Development of Machine Learning Models to Predict Delirium After On-Pump Cardiac Surgery Based on Preoperative and Intraoperative Indices
Scientific Title:Acronym
Development of Machine Learning Models to Predict Delirium After On-Pump Cardiac Surgery Based on Preoperative and Intraoperative Indices
Region
| Japan |
Condition
Condition
Cardiovascular surgery
Classification by specialty
| Cardiovascular surgery | Intensive care medicine | Nursing |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Developing Machine Learning Models to Predict Postoperative Delirium in Cardiovascular Surgery Patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Delirium Occurs within 1 week after surgery.
Key secondary outcomes
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20-89 years undergoing cardiac surgery at Osaka University Hospital from September 2021 to December 2024.
Key exclusion criteria
Catheterization / Preoperative delirium / Patient is diagnosed and treated for dementia / Intubation for more than 4 days after surgery / Re-operation within 7 days after surgery / Cerebral infarction or hemorrhage within 7 days after surgery
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takayoshi |
| Middle name | |
| Last name | Ueno |
Organization
Osaka University Graduate School of Medicine
Division name
Division of Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita-shi, Osaka
TEL
06-6879-5111
uenotm@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Nagata |
Organization
Osaka University Graduate School of Medicine
Division name
Division of Health Science
Zip code
565-0871
Address
1-7 Yamadaoka, Suita-shi, Osaka
TEL
06-6879-5111
Homepage URL
chiezooo17@gmail.com
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Hospital Ethics Review Committee
Address
2-2 Yamadaoka, Suita City, Osaka, Japan Advanced Medical Innovation Center Building 4F
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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 | 11 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Adult patients undergoing cardiac and thoracic vascular surgery at Osaka University Hospital from November 2021 to December 2022 will be included in the study. Data will be collected from the patients' medical records, and cognitive function and depression will be assessed in person. Postoperatively, patients will be followed for 7 days to assess for the occurrence of delirium.
Management information
Registered date
| 2022 | Year | 11 | Month | 01 | Day |
Last modified on
| 2022 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056121
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
