UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014235 |
|---|---|
| Receipt number | R000016581 |
| Scientific Title | The study of the correlation of central venous pressure(CVP) and peripheral venous pressure(PVP) with stroke volume variation(SVV) by Flotrac system in the ICU |
| Date of disclosure of the study information | 2014/06/12 |
| Last modified on | 2017/11/28 17:42:14 |
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Basic information
Public title
The study of the correlation of central venous pressure(CVP) and peripheral venous pressure(PVP) with stroke volume variation(SVV) by Flotrac system in the ICU
Acronym
The study of the correlation of CVP and PVP with SVV
Scientific Title
The study of the correlation of central venous pressure(CVP) and peripheral venous pressure(PVP) with stroke volume variation(SVV) by Flotrac system in the ICU
Scientific Title:Acronym
The study of the correlation of CVP and PVP with SVV
Region
| Japan |
Condition
Condition
patients in the ICU
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Enlarging of the available range of the use of CVP and PVP
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
correlation of CVP and PVP with SVV
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in the ICU with central venous catheter and peripheral venous catheter and arterial blood pressure line
Key exclusion criteria
Patients of during blood purification or using the artificial cardiopulmonary device or with low cardiac function
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Saito |
Organization
Gunma university hospital
Division name
Intensive care unit
Zip code
Address
3-39-15 Showa-machi Maebashi Gunma
TEL
027-220-7111
shigerus@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Yanagisawa |
Organization
Gunma university hospital
Division name
Intensive care unit
Zip code
Address
3-39-15 Showa-machi Maebashi Gunma
TEL
027-220-7111
Homepage URL
aki.yanagisawa@gmail.com
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
Funding Source
Organization
Intensive care unit , Gunma university hospital
Organization
Division
Category of Funding Organization
Other
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
| 2014 | Year | 06 | Month | 12 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Random sampling
the way of respiration or blood pressure or lactate or cardiac index and so on as the factor to examine assoziation
Management information
Registered date
| 2014 | Year | 06 | Month | 11 | Day |
Last modified on
| 2017 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016581
