UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033513 |
|---|---|
| Receipt number | 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 | 2021/01/25 10:12:32 |
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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
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
tetsujiaoyagi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038216
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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