UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002803 |
|---|---|
| Receipt number | R000003410 |
| Scientific Title | A prospective pilot study of the effect of neutrophil elastase on the pulmonary vascular permeability in patients with pneumonia |
| Date of disclosure of the study information | 2009/11/26 |
| Last modified on | 2011/08/21 10:59:52 |
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Basic information
Public title
A prospective pilot study of the effect of neutrophil elastase on the pulmonary vascular permeability in patients with pneumonia
Acronym
Neutrophil elastase and pulmonary vascular permeability index: A prospective pilot study in pneumonia patients
Scientific Title
A prospective pilot study of the effect of neutrophil elastase on the pulmonary vascular permeability in patients with pneumonia
Scientific Title:Acronym
Neutrophil elastase and pulmonary vascular permeability index: A prospective pilot study in pneumonia patients
Region
| Japan |
Condition
Condition
pneumonia
Classification by specialty
| Pneumology | Infectious disease | Laboratory medicine |
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to determine whether an increase in plasma neutrophil elastase is related to elevation of the pulmonary capillary permeability in patients with pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Investigate the relationship between the levels of plasma neutrophil elastase and pulmonary vascular permeability index (PVPI) using the PiCCO system (Pulsion, Munich, Germany).
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pneumonia who were hospitalized from November 2008 to April 2009 and had less than 60 Torr of PaO2 in room air with no need for mechanical ventilation were prospectively enrolled in the study.
Key exclusion criteria
Patient with chronic respiratory failure.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Tagami,MD |
Organization
Aizu chuo hospital
Division name
Department of Emergency & Critical Care Medicine
Zip code
Address
1-1 Tsuruga, Aizuwakamatsu, Fukushima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Aizu chuo hospital
Division name
Department of Emergency & Critical Care Medicine
Zip code
Address
TEL
Homepage URL
tagami.takashi@mbp.nifty.com
Sponsor or person
Institute
Aizu chuo hospital
Institute
Department
Personal name
Funding Source
Organization
Aizu chuo hospital
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
会津中央病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
http://onlinelibrary.wiley.com/doi/10.1111/j.1440-1843.2011.01997.x/abstract
Publication of results
Published
Result
URL related to results and publications
http://onlinelibrary.wiley.com/doi/10.1111/j.1440-1843.2011.01997.x/abstract
Number of participants that the trial has enrolled
Results
Respirology (2011) 16, 953–958
doi: 10.1111/j.1440-1843.2011.01997.x
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
Completed
Date of protocol fixation
| 2008 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 02 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 02 | Month | 01 | Day |
Other
Other related information
Plasma neutrophil elastase levels were collected via blood samples at baseline; 1, 3, and 7 days after the start of the study. Of those enrolled, patients with less than 150 of PaO2/FiO2 also had their extravascular lung water index (EVLWi) and pulmonary vascular permeability index (PVPI) monitored using the PiCCO system (Pulsion, Munich, Germany) when required by their attending physician. Statistical analysis was performed using the Spearman correlation coefficient (Rs) with P value less than 0.05 assumed to be significant.
Management information
Registered date
| 2009 | Year | 11 | Month | 26 | Day |
Last modified on
| 2011 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003410
