UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032802 |
|---|---|
| Receipt number | R000037406 |
| Scientific Title | Efficacy of intravenous immunoglobulin replacement therapy for hypogammaglobulinemia in severe infections |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2018/05/31 10:57:57 |
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Basic information
Public title
Efficacy of intravenous immunoglobulin replacement therapy for hypogammaglobulinemia in severe infections
Acronym
Efficacy of intravenous immunoglobulin replacement therapy for hypogammaglobulinemia in severe infections
Scientific Title
Efficacy of intravenous immunoglobulin replacement therapy for hypogammaglobulinemia in severe infections
Scientific Title:Acronym
Efficacy of intravenous immunoglobulin replacement therapy for hypogammaglobulinemia in severe infections
Region
| Japan |
Condition
Condition
severe infectious diseases
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the patient's characteristics and the improvement of their prognosis by administrating IVIG
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prognosis (ICU mortality rate, 28 days mortality rate, 90-days mortality rate, hospital mortality rate)
Key secondary outcomes
1) characteristics of the patients
2) the severity of organ failure: SOFA score JAAM-DIC score
3) Serum IgG value and IVIG dosage at admitting to the ICU
4) Evaluation of reactivity to the treatment: Changes in SOFA score, Days of vasopressors, Length of ICU days, Hospitalized Days, ventilator days
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
the patients admitted to the ICU during the study period
Key exclusion criteria
1) A case of death or survival within 24 hours after admitting to the ICU
2) Child under 15 years old
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroomi Tatsumi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
Address
South1 West16, Chuo-ku, Sapporo
TEL
011-611-2111
tatsumi@qc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masayuki Akatsuka |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Intensive Care Medicine
Zip code
Address
South1 West16, Chuo-ku, Sapporo
TEL
011-611-2111
Homepage URL
m_a_let_go@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
| 2018 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will analyze the efficacy of intravenous immunoglobulin replacement therapy by collecting data in the future.
Management information
Registered date
| 2018 | Year | 05 | Month | 31 | Day |
Last modified on
| 2018 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037406
