UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019742 |
|---|---|
| Receipt number | R000022802 |
| Scientific Title | A multicenter, prospective observational study for the epidemiology of severe sepsis |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2017/05/01 14:33:14 |
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Basic information
Public title
A multicenter, prospective observational study for the epidemiology of severe sepsis
Acronym
Epidemiology of severe sepsis
Scientific Title
A multicenter, prospective observational study for the epidemiology of severe sepsis
Scientific Title:Acronym
Epidemiology of severe sepsis
Region
| Japan |
Condition
Condition
severe sepsis
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the epidemiology of severe sepsis, to elucidate the pathogenesis of organ dysfunction in severe sepsis and to establish the diagnosis and therapeutic methods for severe sepsis.
Basic objectives2
Others
Basic objectives -Others
28-day and hospital mortality
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The epidemiology of severe sepsis (hospital mortality).
Key secondary outcomes
1. The pathophysiology of severe sepsis and pathogenesis of organ dysfunction in severe sepsis.
2. The diagnosis and treatment of severe sepsis.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who met the definition of severe sepsis according to SCCM/ACCP 1992, SCC/ESICM/ACCP/ATS/SIS 2003 and SSCG 2012.
Key exclusion criteria
None.
Target sample size
613
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | GANDO Satoshi |
Organization
Hokkaido University Graduate School of Medicine
Division name
Acute and Critical Care Medicine
Zip code
Address
N15W7, Kita-ku, Sapporo
TEL
+81-11-706-7377
gando@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SATO Kiyohiko |
Organization
Japanese Association for Acute Medicine
Division name
Japanese Association for Acute Medicine
Zip code
Address
3-3-12, Hongo, Bunkyo-ku, Tokyo
TEL
+81-3-5840-9870
Homepage URL
http://www.jaam.jp/html/jaamforecast/index.html
editorial-jaam@umin.net
Sponsor or person
Institute
Japanese Association for Acute Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Association for Acute Medicine, Japan Society for the Promotion of the Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
http://www.jaam.jp/html/jaamforecast/index.html
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
| 2015 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2017 | Year | 05 | Month | 08 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
The epidemiology of severe sepsis, the pathogenesis of organ dysfunction in severe sepsis and the diagnosis and therapeutic methods for severe sepsis.
Study design: Prospective cohort study
Patients enrollment method: Following patients are eligible for the study. Patients present to emergency department from January to December 2016 and meet the entry criteria
Measurement variables: DIC score, SOFA score, SIRS score, APACHE score etc.
Management information
Registered date
| 2015 | Year | 11 | Month | 11 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022802
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
