UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049747 |
|---|---|
| Receipt number | R000056436 |
| Scientific Title | Identifying Novel Pathophysiology-related Sepsis Endotypes: Exploratory Research |
| Date of disclosure of the study information | 2022/12/12 |
| Last modified on | 2023/12/13 09:54:35 |
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Basic information
Public title
Identifying Novel Sepsis Endotypes
Acronym
Endotype-sepsis study
Scientific Title
Identifying Novel Pathophysiology-related Sepsis Endotypes: Exploratory Research
Scientific Title:Acronym
Endotype-sepsis study
Region
| Japan |
Condition
Condition
Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To identify pathophysiology-related subclasses in patients with sepsis.
To develop the prediction model for sepsis subclasses.
Basic objectives2
Others
Basic objectives -Others
To identify pathophysiology-related subclasses (endotypes) in patients with sepsis.
To develop the prediction model for sepsis subclasses using easily-available clinical data.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Composite outcome of 28-day mortality and/or persistent organ dysfunction. Persistent organ dysfunction is an ongoing requirement for vasopressors, dialysis, or mechanical ventilation.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged greater than or equal to 18 years old diagnosed as sepsis difined by Sepsis-3 diagnostic criteria.
Key exclusion criteria
1. Patients who stay more than 24 hours at the previous hospital before transferring to to the participating hospital.
2. Patients who have sepsis after admission.
3. Patients who have cardiac arrest before obtaining the blood sample.
4. Patients or their legal representatives disagree with participating in the study.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
9800872
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7489
kudodaisuke@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Kudo |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
9800872
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7489
Homepage URL
kudodaisuke@med.tohoku.ac.jp
Sponsor or person
Institute
Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Diverta Inc.
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
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
東北大学病院（宮城県）、北海道大学病院（北海道）、大阪医科薬科大学病院（大阪府）、岡山大学病院（岡山大学）、順天堂大学浦安病院（千葉県）、水戸医療センター（茨城県）、慶応義塾大学病院（東京都）、広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection
1. Patient background
2. Clinical data
3. Genome and genome-wide association analysis
4. Metabolite and metabolome analysis
2. Subclass clustering
We will integrate the patient background, clinical data, genome data, and metabolome data. Then, we will do subclass clustering by machine learning, such as spectral clustering using a fused affinity matrix or other methods. We will examine the outcome and efficacy of treatments on patients in each cluster.
Management information
Registered date
| 2022 | Year | 12 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056436
