UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000524 |
|---|---|
| Receipt number | R000000635 |
| Scientific Title | Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia |
| Date of disclosure of the study information | 2006/11/17 |
| Last modified on | 2017/05/02 13:56:37 |
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Basic information
Public title
Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Acronym
Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Scientific Title
Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Scientific Title:Acronym
Effects of sivelestat sodium in acute respiratory failure caused by sever pneumonia
Region
| Japan |
Condition
Condition
Acute respiratory failure caused by sever pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical effects of sivelestat sodium in sever pneumonia and acute respiratory failure receiving NPPV
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration of ventilatiory assistance, need for endotracheal intubation and mechanical ventilation
Key secondary outcomes
PaO2/FiO2 ratio, in-hospital survival
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Control (usual therapy) group: Initial antibiotic administration following the JRS/ATS/IDSA guidelines, and later adjusted to the results of bacterial culture results and antibiogram. Non invasive positive pressure ventilation following the JRS guideline, and oxygen administration adjusted to achieve a level of arterial oxygen saturation above 90%. Bronchodilator therapy and chest physiotherapy as needed and tolerated.
Interventions/Control_2
Intervention group: usual therapy plus intravenous administration of sivelestat sodium.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Sever pneumonia and acute respiratory failure receiving NPPV
Key exclusion criteria
Respiratory arrest, respiratory pause with loss of consciousness, sever hemodynamic instability
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichi Kobayashi |
Organization
Ishinomaki Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Nishimichishita 71, Hebita, Ishinomaki, Miyagi
TEL
0225-21-7220
skoba-thk@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichi Kobayashi |
Organization
Ishinomaki Red Cross Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
Nishimichishita 71, Hebita, Ishinomaki, Miyagi
TEL
0225-21-7220
Homepage URL
skoba-thk@umin.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Ishinomaki Red Cross 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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 11 | Month | 17 | 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
| 2006 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2008 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 11 | Month | 17 | Day |
Last modified on
| 2017 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000635
