UMIN-CTR Clinical Trial

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	Completed
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	2021 Year 01 Month 25 Day

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