UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033038 |
|---|---|
| Receipt number | R000037622 |
| Scientific Title | Investigation of the effect of inflammation on delirium |
| Date of disclosure of the study information | 2018/06/18 |
| Last modified on | 2023/06/01 14:18:53 |
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Basic information
Public title
Investigation of the effect of inflammation on delirium
Acronym
inflammation and delirium
Scientific Title
Investigation of the effect of inflammation on delirium
Scientific Title:Acronym
inflammation and delirium
Region
| Japan |
Condition
Condition
Head and Neck cancer, esophageal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Oto-rhino-laryngology |
| Anesthesiology | Oral surgery | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is thought that postoperative delirium or ICU delirium is likely to occur by adding severe inflammation to change neuronal activity associated with aging. We try to find any relationship between inflammation and delirium, and to search what factor of the patient could induce delirium. We will search predictive factors that cause onset and development of the delirium. For this purpose, we will test EEG analysis combined with some inflammation related substance such as Lipocaline2(LCN2), We also expect to establish a method that could prevent the inflammation induced delirium.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between inflammatory markers and EEG
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement and analysis of Bispectral index (BIS) Monitor and inflammatory markers
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo head and neck or esophageal cancer surgery at Hirosaki University hospital
Key exclusion criteria
Case without agreement of informed consent
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | HIROTAKA |
| Middle name | |
| Last name | KINOSHITA |
Organization
Hirosaki University Hospital
Division name
Department of Anesthesiology
Zip code
036-8563
Address
53 Hon-cho, Hirosaki City, Aomori Pref, Japan
TEL
0172-33-5111
hirotakak@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | HIROTAKA |
| Middle name | |
| Last name | KINOSHITA |
Organization
Hirosaki University Hospital
Division name
Department of Anesthesiology
Zip code
036-8563
Address
53 Hon-cho, Hirosaki City, Aomori Pref, Japan
TEL
0172-39-5111
Homepage URL
hirotakak@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology,Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Science and Technology Agency
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
Ethics Committee, Hirosaki University Graduate School of Medicine
Address
5 Zaifu-cho, Hirosaki City, Aomori Pref, Japan
Tel
0172-39-5194
jm5194@cc.hirosaki-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
| 2018 | Year | 06 | Month | 18 | 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
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 18 | Day |
Last modified on
| 2023 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037622
| 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 |
