UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037743 |
|---|---|
| Receipt number | R000043047 |
| Scientific Title | The relationship between regional Cerebral Oxygen Saturation and pediatric delirium and sedation after cardiac surgery |
| Date of disclosure of the study information | 2019/08/22 |
| Last modified on | 2019/08/20 15:06:41 |
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Basic information
Public title
The relationship between regional Cerebral Oxygen Saturation and pediatric delirium and sedation after cardiac surgery
Acronym
The relationship between regional Cerebral Oxygen Saturation and pediatric delirium and sedation after cardiac surgery
Scientific Title
The relationship between regional Cerebral Oxygen Saturation and pediatric delirium and sedation after cardiac surgery
Scientific Title:Acronym
The relationship between regional Cerebral Oxygen Saturation and pediatric delirium and sedation after cardiac surgery
Region
| Japan |
Condition
Condition
Enrollment criteria included patients aged under 18 years, undergoing scheduled cardiovascular patients.
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is revealing the association between Regional Cerebral Oxygen Saturation and pediatric delirium after cardiac surgery
Basic objectives2
Others
Basic objectives -Others
relationship
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of delirium.
Key secondary outcomes
The relation between each item of delirium and Regional Cerebral Oxygen Saturation.
Delirium days.
Delirium coma-free days.
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Enrollment criteria included patients aged under 18 years, undergoing scheduled cardiovascular between August 2019 to February 2021.
Key exclusion criteria
Patients were excluded if they diagnosed with brain dysfunction.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Inoue |
Organization
University of Tsukuba
Division name
Department of Emergency and Critical Care Medicine, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba-shi, Ibaraki, Japan
TEL
029-853-5633
er-icu@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yujiro |
| Middle name | |
| Last name | Matsuishi |
Organization
University of Tsukuba
Division name
Department of Emergency and Critical Care Medicine, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennoudai, Tsukuba-shi, Ibaraki, Japan
TEL
029-853-5633
Homepage URL
matsuishi.yujiro.xa@alumni.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of the University of Tsukuba
Address
1-1-1 Tennoudai, Tsukuba-shi, Ibaraki, Japan
Tel
0298533941
t-credo.adm@un.tsukuba.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 | 08 | Month | 22 | 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
| 2019 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 08 | Month | 20 | Day |
Last modified on
| 2019 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043047
