UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028157
Receipt number 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 2020/07/12 09:42:40

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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 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 or person

Institute

Tottori University Hospital

Institute

Department

Personal name



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

Value
https://center6.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