UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023085 |
|---|---|
| Receipt number | R000026458 |
| Scientific Title | Investigative research for the development of new diagnostic system for sepsis |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2024/08/14 13:10:50 |
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Basic information
Public title
Investigative research for the development of new diagnostic system for sepsis
Acronym
Investigative research for new diagnostic system for sepsis
Scientific Title
Investigative research for the development of new diagnostic system for sepsis
Scientific Title:Acronym
Investigative research for new diagnostic system for sepsis
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using the portable prototype that used the backscattering method for principle of measurement, we measure endotoxin levels in patients suffering from sepsis and compare the clinical statue and endotoxin levels at EAA method.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mortality at 7th day, 28th day and 90th day
Key secondary outcomes
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
The patients suspected sepsis
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Kitamura |
Organization
Shiga University of Medical Science
Division name
Critical and Intensive Medicine
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL
077-548-2929
naomik@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Kitamura |
Organization
Shiga University of Medical Science
Division name
Critical and Intensive Medicine
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
TEL
077-548-2929
Homepage URL
hqqqicu@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science and Technology
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
Shiga University of Medical Science
Address
Seta Tsukinowa-cho, Otsu City,Shiga,JAPAN
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2016 | Year | 07 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
SIRS, SOFA score, culture of blood,urine,sputum and ascites, blood examination, vital signs, endotoxin concentration
Management information
Registered date
| 2016 | Year | 07 | Month | 08 | Day |
Last modified on
| 2024 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026458
