UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033038
Receipt No. R000037622
Scientific Title Investigation of the effect of inflammation on delirium
Date of disclosure of the study information 2018/06/18
Last modified on 2018/11/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kinoshita hirotaka
Organization Hirosaki University Hospital
Division name Department of Anesthesiology
Zip code
Address 53 Hon-cho, Hirosaki City, Aomori Pref, Japan
TEL 0172-33-5111
Email hirotakak@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name HIROTAKA KINOSHITA
Organization Hirosaki University Graduate School of Medicine
Division name Department of Anesthesiology
Zip code
Address 5 Zaifu-cho, Hirosaki City, Aomori Pref, Japan
TEL 0172-39-5113
Homepage URL
Email hirotakak@hirosaki-u.ac.jp

Sponsor
Institute Department of Anesthesiology,Hirosaki University Graduate School of Medicine
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 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
2018 Year 06 Month 18 Day
Last modified on
2018 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.