UMIN-CTR Clinical Trial

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 Masaaki Middle name Last name Iwata
Organization	Tottori University Hospital
Division name	Division of Neuropsychiatry
Zip code	683-0826
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 Iwata Middle name Last name Masaaki
Organization	Tottori University Hospital
Division name	Division of Neuropsychiatry
Zip code	683-0826
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	Tottori University Hospital Institutional Review Board
Address	36-1 Nishi-cho, Yonago, Tottori
Tel	0859-33-1111
Email	crsc@ml.med.tottori-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	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	20
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	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 06 Day
Date of IRB	2017 Year 06 Month 08 Day
Anticipated trial start date	2017 Year 07 Month 12 Day
Last follow-up date	2022 Year 05 Month 30 Day
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	2020 Year 07 Month 12 Day

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