UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046236 |
|---|---|
| Receipt number | R000049197 |
| Scientific Title | Analysis of Bronchoalveolar Lavage to Assess Local Immunopathology in Severe Pneumonia (Focus on sTREM, Alveolar Macrophage, IL-6, IL-17, CD4, T-reg, Surfactant Protein-A, and Caspase-3) |
| Date of disclosure of the study information | 2021/11/30 |
| Last modified on | 2022/04/18 14:48:15 |
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Basic information
Public title
Analysis of Bronchoalveolar Lavage to Assess Local Immunopathology
Acronym
ABLALI
Scientific Title
Analysis of Bronchoalveolar Lavage to Assess Local Immunopathology in Severe Pneumonia (Focus on sTREM, Alveolar Macrophage, IL-6, IL-17, CD4, T-reg, Surfactant Protein-A, and Caspase-3)
Scientific Title:Acronym
ABLALISP
Region
| Asia(except Japan) |
Condition
Condition
Severe Pneumonia
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine differences of local immunopathology response between right and left lung of severe pneumonia patients
Basic objectives2
Others
Basic objectives -Others
To assess immunopathology response differences in severe pneumonia patients with extubation failure and mortality
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Extubation failure at 19 days
Key secondary outcomes
Mortality after 28 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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
18 years or older, severe pneumonia according to IDSA/ATS criteria, can undergo bronchoscopy within 12 hours, received empirical antibiotics in less than 24 hours, intubated within < 24 hours
Key exclusion criteria
non-infectious acute respiratory distress syndrome, HIV/AIDS, active malignancy within 12 months, under immunosuppressants, refuse to undergo bronchoscopy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Gurmeet |
| Middle name | |
| Last name | Singh |
Organization
Indonesian Doctors Association
Division name
Respirology and Critical Care
Zip code
13310
Address
Jl. Diponegoro No. 71
TEL
081385158159
gurmeetsingh10@yahoo.com
Public contact
Name of contact person
| 1st name | Gurmeet |
| Middle name | |
| Last name | Singh |
Organization
Indonesian Doctors Association
Division name
Respirology and Critical Care
Zip code
13310
Address
Jl. Diponegoro No. 71
TEL
081385158159
Homepage URL
gurmeetsingh10@yahoo.com
Sponsor or person
Institute
PERPARI - Indonesian Respirology Society
Institute
Department
Personal name
Funding Source
Organization
PERPARI - Indonesian Respirology Society
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Universitas Indonesia
Address
Jl. Salemba No. 6 Jakarta
Tel
0213157008
ec_fkui@yahoo.com
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
| 2021 | Year | 11 | Month | 30 | 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
40
Results
There was a significance difference on local immunopathology response of CD4 BAL between right and left lung of severe pneumonia patients (p = 0,003). There was a significance difference of CD4 BAL in severely affected lung on extubation 19 days (p = 0,01) and mortality 28 days (p = 0,004). There were kinetic interactions between alveolar macrophage function, IL-6, IL-17, CD4, and Treg in severely affected lung on the extubation and mortality status.
Results date posted
| 2021 | Year | 11 | Month | 30 | Day |
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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 17 | Day |
Date of closure to data entry
| 2020 | Year | 10 | Month | 20 | Day |
Date trial data considered complete
| 2021 | Year | 01 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 03 | Day |
Other
Other related information
Admitted ER patients who fulfilled inclusion criteria or hospitalized at ICU accepted the informed consent for the researcher to collect the data (based on research form). Bronchoscopy will then be conducted within 12 hours for specimen collection in the right and left lung. Patients then were observed for 19 days to assess the extubation status and will be continued for 28 days for the mortality status.
Management information
Registered date
| 2021 | Year | 11 | Month | 30 | Day |
Last modified on
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049197
