UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002780 |
|---|---|
| Receipt number | 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 08:53:30 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003382
