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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033513
Receipt No. R000038216
Scientific Title The possibility of IL-36 cytokines as a novel biomarker of the severity and mortality in the patients with bacteremia or sepsis.
Date of disclosure of the study information 2018/07/25
Last modified on 2019/07/28

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Basic information
Public title The possibility of IL-36 cytokines as a novel biomarker of the severity and mortality in the patients with bacteremia or sepsis.
Acronym The role of IL-36 cytokines in sepsis.
Scientific Title The possibility of IL-36 cytokines as a novel biomarker of the severity and mortality in the patients with bacteremia or sepsis.
Scientific Title:Acronym The role of IL-36 cytokines in sepsis.
Region
Japan

Condition
Condition Bacteremia and Sepsis
Classification by specialty
Infectious disease Emergency medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether IL-36 cytokines can be a predictive marker of the severity and mortality in the patients with bacteremia or sepsis.
Basic objectives2 Others
Basic objectives -Others Are IL-36 cytokines packed in the extracellular vesicles in sepsis patients ?
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The production of IL-36 cytokines
Severity and mortality
Key secondary outcomes Extracellular microvesicles

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) The patients who are hospitalized with bacteremia or sepsis at department of emergency room at Tohoku university hospital.
(2) The patients who are over 20 years old. Informed consent are obtained from the patients themselves and their relatives if we can not obtain informed consent from the patients with severe condition.
(3) Gender: not applicable
(4) Healthy volunteers
- over 20 years old
- gender: not applicable
- who can obtain informed consent

Key exclusion criteria (1) The person who are under 20 years old
(2) Pregnancy
(3) The person whom we can not obtain the informed consent.
(4) Not appropriate as a physician's judgement
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Tetsuji
Middle name
Last name Aoyagi
Organization Tohoku University
Division name Department of Infectious Diseases
Zip code 980-8574
Address 1-1 Seiryo-machi, Aobaku, Sendai, Japan
TEL 0227177373
Email tetsujiaoyagi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Tetuji
Middle name
Last name Aoyagi
Organization Tohoku University
Division name Department of Infectious Diseases
Zip code 980-8574
Address 1-1 Seiryo-machi, Aobaku, Sendai, Japan
TEL 0227177373
Homepage URL
Email tetsujiaoyagi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University Graduate School of Medicine
Address 1-2, Seiryo-machi, Aobaku, Sendai, Japan
Tel 022-717-7700
Email med-kenkyo@grp.tohoku.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 07 Month 25 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 06 Month 01 Day
Date of IRB
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 07 Month 30 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information plasma, IL-36 cytokines, extracellular vesicles, patient's demographic, severity, mortality

Management information
Registered date
2018 Year 07 Month 25 Day
Last modified on
2019 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038216

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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