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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002780
Receipt No. R000003382
Scientific Title Validation of the extravascular lung water by single transpulmonary thermodilution
Date of disclosure of the study information 2009/11/19
Last modified on 2010/09/09

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Basic information
Public title Validation of the extravascular lung water by single transpulmonary thermodilution
Acronym Validation of the extravascular lung water by the PiCCO system
Scientific Title Validation of the extravascular lung water by single transpulmonary thermodilution
Scientific Title:Acronym Validation of the extravascular lung water by the PiCCO system
Region
Japan

Condition
Condition Pulmonary edema
Classification by specialty
Pneumology Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Validate the accuracy of extravascular lung water (EVLW) measured by the PiCCO system
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Investigate the relationship between the EVLW measured by the PiCCO system and postmortem lung weight.
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 We studied consecutive autopsy cases whose EVLW were measured by the PiCCO system just prior to death
Key exclusion criteria We chose 48 hours as a cut-off point for inclusion in the study because the postmortem lung weight is known to change little in the early postmortem period (4.5-72 hours)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Tagami
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 1-1 Tsuruga, Aizuwakamatsu, Fukushima, Japan
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

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 19 Day

Related information
URL releasing protocol http://ccforum.com/content/14/5/R162
Publication of results Published

Result
URL related to results and publications http://ccforum.com/content/14/5/R162
Number of participants that the trial has enrolled
Results
A definite correlation exists between EVLW measured by the single-indicator transpulmonary thermodilution technique and post-mortem lung weight in humans. The normal EVLW value is approximately 7.4 +/- 3.3 mL/kg. 
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
2004 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2004 Year 07 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We studied the relationship between the EVLW measured by the PiCCO system and postmortem lung weight. Linear regression line equation was calculated if the relationship was statistically significant.

Management information
Registered date
2009 Year 11 Month 19 Day
Last modified on
2010 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003382

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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