UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011377 |
|---|---|
| Receipt number | R000013324 |
| Scientific Title | Comparison between central venous pressure (CVP) and stroke volume variation (SVV) as an indicator for management of fluid transfusion in patients undergoing hepatectomy |
| Date of disclosure of the study information | 2013/08/06 |
| Last modified on | 2015/08/05 10:21:06 |
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Basic information
Public title
Comparison between central venous pressure (CVP) and stroke volume variation (SVV) as an indicator for management of fluid transfusion in patients undergoing hepatectomy
Acronym
Comparison between central venous pressure and stroke volume variation
Scientific Title
Comparison between central venous pressure (CVP) and stroke volume variation (SVV) as an indicator for management of fluid transfusion in patients undergoing hepatectomy
Scientific Title:Acronym
Comparison between central venous pressure and stroke volume variation
Region
| Japan |
Condition
Condition
liver diseases
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy as an indicator for management of fluid transfusion during hepatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Realationship between the valus of CVP/SVV and the volume of intraoperative blood loss/fluid transfused
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
invasive blood pressure, central venous pressure, oxygen saturation in central venous blood
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients undergoing hepatectomy
Key exclusion criteria
arrhythmia
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Ushijima |
Organization
Kurume University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-31-7578
kazush@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YUkari Koga |
Organization
Kurume University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
67 Asahi-machi, Kurume city, Fukuoka
TEL
0942-31-7578
Homepage URL
koga-yukari@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2013 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
No significant relationship was observed between SVV and CVP in patients undergoing hepatectomy.
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
Main results already published
Date of protocol fixation
| 2013 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 05 | Day |
Last modified on
| 2015 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013324
