UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005422 |
|---|---|
| Receipt number | R000005880 |
| Scientific Title | A pilot study the effectiveness of immune globulin for ALI / ARDS |
| Date of disclosure of the study information | 2011/04/12 |
| Last modified on | 2013/04/11 09:14:34 |
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Basic information
Public title
A pilot study the effectiveness of immune globulin for ALI / ARDS
Acronym
A pilot study the effectiveness of immune globulin for ALI / ARDS
Scientific Title
A pilot study the effectiveness of immune globulin for ALI / ARDS
Scientific Title:Acronym
A pilot study the effectiveness of immune globulin for ALI / ARDS
Region
| Japan |
Condition
Condition
ALI/ARDS due to sepsis
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ensure the biological effects of inflammatory mediators caused by IVIG for patients with ALI/ARDS due to sepsis
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Variation of septic inflammation markers (IL-6, TNF-a, CRP, PCT, HMGB-1, etc.)
Key secondary outcomes
1) Duration to recover from ALI/ARDS
2) Duration to recover from SIRS
3) The survival rate after 30 days
4) The period of ventilator use [VFD (Ventilator Free Days): survival time in a state that seceded from the ventilator 28 days]
5) Inspection infections (WBC, neutrophil count, the number of peripheral blood lymphocytes, the serum IgG and albumin)
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Freeze-Dried Sulfonated Human Normal Immunoglobulin
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
1) Patients clinically diagnosed as ALI / ARDS due to sepsis
2) Over 18 years of age, gender does not matter
Key exclusion criteria
1) Patients with a history of allergy or shock to the components of the immune globulin
2) Patients with severe liver damage (for example: patients with cirrhosis), however, derived from liver failure include sepsis.
3) Patients with severe renal failure (for example: chronic dialysis patients), however, derived from kidney failure include sepsis.
4) Patients with sepsis due to hematological malignancies
5) Patients in the treatment of malignant tumors
6) Patients treated with immunosuppressive drugs such as cyclosporine
7) Patients with less than 1000 granulocytes / mm2 due to any reasons other than sepsis
8) Patients who develop chronic heart failure or acute myocardial infarction within the last six weeks
9) Patients who are judged to be inappropriate by doctor
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Kinoshita |
Organization
Jikei University Daisan-Hospital
Division name
Division of Respirology, department of internal medicine
Zip code
Address
4-11-1, Izumi-honcho, Komae-shi, Tokyo, 201-8601 Japan
TEL
03-3480-1151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Seki |
Organization
Jikei University Daisan-Hospital
Division name
Division of Respirology, department of internal medicine
Zip code
Address
4-11-1, Izumi-honcho, Komae-shi, Tokyo, 201-8601 Japan
TEL
03-3480-1151
Homepage URL
ms97-seki@jikei.ac.jp
Sponsor or person
Institute
Division of Respirology, department of internal medicine, Jikei University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
東京慈恵会医科大学付属第三病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 04 | Month | 12 | 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
| 2011 | Year | 01 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 11 | Day |
Last modified on
| 2013 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005880
