UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036373 |
|---|---|
| Receipt number | R000041438 |
| Scientific Title | Immunoglobulin correlates with the severity in septic patients |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2020/04/01 09:12:03 |
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Basic information
Public title
Immunoglobulin correlates with the severity in septic patients
Acronym
Correlation between immunoglobulin and severity of sepsis
Scientific Title
Immunoglobulin correlates with the severity in septic patients
Scientific Title:Acronym
Correlation between immunoglobulin and severity of sepsis
Region
| Japan |
Condition
Condition
Infection disease/ Sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of correlation between the level of serum Ig and the severity in infection disease and sepsis
Basic objectives2
Others
Basic objectives -Others
Analysis of correlation between the level of serum Ig and rapid turnover protein in infection disease and sepsis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
severity score(SOFA score)
Key secondary outcomes
rapid turnover protein
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
>17 years, hospitalized patients caused by infection
Key exclusion criteria
<18 years
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Ogura |
Organization
Gifu University Graduate School of Medicine
Division name
Department of emergency and disaster medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6448
oguras@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideshi |
| Middle name | |
| Last name | Okada |
Organization
Gifu University Graduate School of Medicine
Division name
Department of emergency and disaster medicine
Zip code
5011194
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6448
Homepage URL
hideshi@gifu-u.ac.jp
Sponsor or person
Institute
Department of emergency and disaster medicine, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of emergency and disaster medicine, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board for Clinical Research of Gifu University
Address
1-1 Yanagido, Gifu 501-1194, Japan
Tel
058-230-6059
rinri@gifu-u.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
| 2019 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analize the correlation between the level of serum Ig and severity in infection disease or/and septic patients enrolled between January 2008 and December 2015 retrospectively.
Management information
Registered date
| 2019 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041438
