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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002803
Receipt No. 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

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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
Email

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
Email tagami.takashi@mbp.nifty.com

Sponsor
Institute Aizu chuo hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003410

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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