UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052620 |
|---|---|
| Receipt number | R000060044 |
| Scientific Title | Immunoglobulin therapy for sepsis with hypogammaglobulinemia -a multicenter randomized controlled trial- |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2024/10/25 09:24:11 |
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Basic information
Public title
IVIG therapy for the patients with hypogammaglobulinemia in sepsis -a multicenter randomized controlled trial-
Acronym
Immunoglobulin therapy for sepsis with hypogammaglobulinemia
Scientific Title
Immunoglobulin therapy for sepsis with hypogammaglobulinemia -a multicenter randomized controlled trial-
Scientific Title:Acronym
Immunoglobulin therapy for sepsis with hypogammaglobulinemia
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of IVIG therapy for sepsis with hypoIgGemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of death or organ failure 14 days after allocation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single dose of IVIG 500 mg/kg
Interventions/Control_2
Administer placebo (the same amount of saline as IVIG) without administering IVIG
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
Sepsis or septic shock patients admitted to the intensive care unit with hypogammaglobulinemia (IgG<670 mg/dL)
Key exclusion criteria
Under 18 years old
Congenital hypoammaglobulinemia or agammaglobulinemia
Experienced cardiac arrest before randomization
Received IVIG in the 30 days before randomization
End-stage liver failure
After organ transplant
Expressed their intention to restrict treatment in some way by themselves or their legal guardian
Expressed their intention to refuse participation in this study
Any other information that the research representative (responsible person) or co-partner deems inappropriate to participate in the research.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Akatsuka |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
0608543
Address
South1 West16, Chuo-ku, Sapporo
TEL
011-611-2111
m.akatsuka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Akatsuka |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
0608543
Address
South1 West16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
m.akatsuka@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Clinical Trial Group of the Japanese Society of Intensive Care Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Sapporo Medical University Hospital
Address
South1 West16, Chuo-ku, Sapporo
Tel
011-611-2111
ji-rskk@sapmed.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
| 2023 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | 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
Management information
Registered date
| 2023 | Year | 10 | Month | 26 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060044
