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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028157
Receipt No. R000032006
Scientific Title A study of the relationship between postoperative delirium and inflammatory markers.
Date of disclosure of the study information 2017/07/10
Last modified on 2017/07/10

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Basic information
Public title A study of the relationship between postoperative delirium and inflammatory markers.
Acronym Postoperative delirium and inflammatory markers
Scientific Title A study of the relationship between postoperative delirium and inflammatory markers.
Scientific Title:Acronym Postoperative delirium and inflammatory markers
Region
Japan

Condition
Condition Postoperative delirium
Classification by specialty
Gastrointestinal surgery Psychiatry
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate inflammatory markers which are thought to be related with the onset and severity of delirium on the patients who are participating in the clinical study carried out in our hospital named "Evaluation of the efficacy of yokukansan for postoperative delirium".
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between the presence/severity of delirium and inflammatory markers (NLRP3, IL-1beta, IL-6, IL-8, IL-18, TNF -alpha in serum or mononuclear leukocyte), and the effects of yokukansan.
Key secondary outcomes Correlation between the inflammatory markers
Association between safety, harmful phenomenon and inflammatory markers

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Yokukansan group take 2.5 g of yokukansan before every meal from the morning of the previous day until the morning of the operation day. After surgery, patients start taking yokukansan as soon as possible and take until the 3rd postoperative day. Blood is collected on the day before operation, and first and third day after the operation.
Interventions/Control_2 Control group take 2.5 g of anchusan before every meal from the morning of the previous day until the morning of the operation day. After surgery, patients start taking anchusan as soon as possible and take until the 3rd postoperative day. Blood is collected on the day before operation, and first and third day after the operation.
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
75 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The man and woman who agrees to the participation of the study named "Evaluation of the efficacy of yokukansan for postoperative delirium".
Key exclusion criteria None.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Iwata
Organization Tottori University Hospital
Division name Division of Neuropsychiatry
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori
TEL 0859-38-6547
Email yanmasa@f8.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaaki Iwata
Organization Tottori University Hospital
Division name Division of Neuropsychiatry
Zip code
Address 36-1 Nishi-cho, Yonago, Tottori
TEL 0859-38-6547
Homepage URL
Email yanmasa@f8.dion.ne.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

Funding Source
Organization Tottori University Hospital
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
Address
Tel
Email

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
2017 Year 07 Month 10 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 06 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 10 Day
Last modified on
2017 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032006

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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