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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005422
Receipt No. 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

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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
Email

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
Email ms97-seki@jikei.ac.jp

Sponsor
Institute Division of Respirology, department of internal medicine, Jikei University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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