UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036436 |
|---|---|
| Receipt number | R000041517 |
| Scientific Title | Predicting for development of delirium in intensive care unit using bedside physiological monitoring |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2022/04/08 09:55:48 |
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Basic information
Public title
Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Acronym
Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Scientific Title
Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Scientific Title:Acronym
Predicting for development of delirium in intensive care unit using bedside physiological monitoring
Region
| Japan |
Condition
Condition
cardiovascular surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Can we predict the onset of delirium in the intensive care unit using bedside physiological monitoring?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Can we predict the onset of delirium in the intensive care unit using bedside physiological monitoring?
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Open-heart surgery and major vessel surgery
Key exclusion criteria
History of mental illness
Patients with dementia
Unconscious
The person in charge of research judged it to be inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Maiko |
| Middle name | |
| Last name | Satomoto |
Organization
Toho University
Division name
Anesthesiology
Zip code
1438541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
0337624151
maiko.satomoto@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Satomoto |
Organization
Toho University
Division name
Research consultation desk
Zip code
1438541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL
0337624151
Homepage URL
maiko.satomoto@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Toho University
Address
Ota-ku
Tel
0337624161
maiko.satomoto@med.toho-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
| 2019 | Year | 05 | 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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Analysis data (sample) protects personal information by deleting identifiable personal information (anonymization). In anonymization, random numbering is performed in Excel to create a correspondence table. Also, all information files are used with a password, and the stored USB and paper media information is also stored in a locker locker and not used on PCs that can connect to the Internet environment. Analysis data after the end of the study is stored by a research executor in a locker that takes 10 years.
Management information
Registered date
| 2019 | Year | 04 | Month | 07 | Day |
Last modified on
| 2022 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041517
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
