UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010372 |
|---|---|
| Receipt number | R000012137 |
| Scientific Title | Evaluation of usefullness of IVIG for sever sepsis |
| Date of disclosure of the study information | 2013/04/08 |
| Last modified on | 2020/04/06 13:34:34 |
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Basic information
Public title
Evaluation of usefullness of IVIG for sever sepsis
Acronym
Usefullness of IVIG
Scientific Title
Evaluation of usefullness of IVIG for sever sepsis
Scientific Title:Acronym
Usefullness of IVIG
Region
| Japan |
Condition
Condition
Severe sepsis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the inflammation- markers before and after administration of IVIG.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We evaluate inflammation-makers.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Blood sampling
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with sever sepsis
Key exclusion criteria
Patients with allergy for IVIG
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Kumamoto |
Organization
Yokohama City University Graduate School of Medicine.
Division name
Department of Gastroenterologycal Surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004 Japan
TEL
045-787-2650
t.kumamoto@k5.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Kumamoto |
Organization
Yokohama City University Graduate School of Medicine.
Division name
Department of Gastroenterologycal Surgery
Zip code
Address
t.kumamoto@k5.dion.ne.jp
TEL
045-787-2650
Homepage URL
t.kumamoto@k5.dion.ne.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine.
Institute
Department
Personal name
Funding Source
Organization
Yokohama City 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
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
| 2013 | Year | 04 | Month | 08 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 31 | Day |
Last modified on
| 2020 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012137
