UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056142 |
|---|---|
| Receipt number | R000064148 |
| Scientific Title | Exploratory study of biomarkers and genetic polymorphisms influencing severity and clinical course using a nationwide Japanese sepsis database |
| Date of disclosure of the study information | 2024/11/13 |
| Last modified on | 2024/11/13 14:07:05 |
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Basic information
Public title
Japan Sepsis Data Bank
Acronym
JSDB
Scientific Title
Exploratory study of biomarkers and genetic polymorphisms influencing severity and clinical course using a nationwide Japanese sepsis database
Scientific Title:Acronym
Exploratory study of biomarkers and genetic polymorphisms influencing severity and clinical course using a nationwide Japanese sepsis database
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Our objective is to establish a comprehensive sepsis registry that will collect clinical data and serve as a databank. The databank aims to identify biomarkers that can predict the onset of severe sepsis in patients and to develop a system for early detection
Basic objectives2
Others
Basic objectives -Others
The biobank aims to investigate biomarkers and genetic polymorphisms that impact the severity of sepsis and its response to treatment.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28-day survival, hospital survival, ICU survival, 90-day survival
Key secondary outcomes
Biomarkers and genetic polymorphisms that impact the severity of sepsis and its response to treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Research subjects who are registered only in the databank must satisfy 1) and 3) below.
For research subjects for whom specimens will be collected, all of the following 1), 2), and 4) must be met
1) Patients who have been diagnosed with sepsis according to the Sepsis-3 definition and admitted to the ICU
2) Patients who have given written consent to participate in the study
(3) Research subjects who have not expressed their refusal to participate in this study after receiving an explanation of the study in a release of information document (opt-out document)
4) Adults who are at least 18 years of age, either as the person obtaining consent or as a surrogate.
Key exclusion criteria
1) Research subjects who are not eligible for multidisciplinary treatment for sepsis
2) Research subjects who are judged by the investigator or others to be inappropriate for inclusion in the study
3) Subjects who have expressed their refusal to participate in this study through the information disclosure document.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Nakada |
| Middle name | |
| Last name | Taka-aki |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
TEL
+81-43-226-2372
seveneleven711thanks39@msn.com
Public contact
Name of contact person
| 1st name | Oami |
| Middle name | |
| Last name | Takehiko |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
TEL
+81-43-226-2372
Homepage URL
https://www.jaam.jp/info/2023/info-JSDB_1.html
seveneleven711thanks39@msn.com
Sponsor or person
Institute
Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Acute Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo, Chiba 260-8677, Japan
Tel
0432227171
chibadaieccm-office@umin.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
1. 千葉大学医学部附属病院
2. 大阪医科大学附属病院
3. 筑波記念病院 救急科
4. 広島大学大学院 医系科学研究科 救急集中治療医学
5. 獨協医科大学病院 救命救急センター・集中治療室
6. 東北大学病院 救急科・高度救命救急センター
7. 東京大学大学院医学系研究科 救急・集中治療医学
8. 聖マリアンナ医科大学 小児科
9. 公立西知多総合病院 救急科
10. 浜松医科大学医学部附属病院 集中治療部
11. 北海道大学大学院医学研究院侵襲制御医学分野救急医学教室
12. 国立国際医療研究センター病院
13. 横浜市立大学 医学部麻酔科学
14. 国立大学法人 三重大学医学部附属病院 高度救命救急・総合集中治療センター
15. 防衛医科大学校病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subject and study design:
After the principal investigator or research scientist confirms that the potential subject meets the selection criteria and does not violate the exclusion criteria, the subject will be assigned a subject ID and included in the study.No intervention will be used to obtain clinical data, but medical information will be collected, including basic patient information, diagnosis, and treatment.
Regarding biobanks, researchers at each research site will transport all anonymized samples (e.g., blood samples) of subjects who have given consent to the biobank to the administrative office after appropriate processing such as centrifugation. Serum and plasma extracted from blood specimens will be stored at the Graduate School of Emergency and Intensive Care Medicine, Chiba University Graduate School of Medicine, and DNA will be extracted from peripheral blood mononuclear cells.
The Emergency and Intensive Care Medicine of Chiba University Graduate School of Medicine will measure various protein levels, including cytokines, in the patient's serum. In addition, DNA sequencing and RNA expression analysis obtained from peripheral blood mononuclear cells of patients will be performed. We will search for genes associated with severe disease. In addition, the immune cell population and each cell surface antigen in peripheral blood mononuclear cells will be analyzed using a flowcytometer.
Management information
Registered date
| 2024 | Year | 11 | Month | 13 | Day |
Last modified on
| 2024 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064148
