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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044015
Receipt No. R000050262
Scientific Title Effect of intraoperative repositioning on Central Venous Pressure (CVP) and Stroke Volume Variation (SVV)
Date of disclosure of the study information 2021/05/17
Last modified on 2021/05/17

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Basic information
Public title Effect of intraoperative repositioning on Central Venous Pressure (CVP) and Stroke Volume Variation (SVV)
Acronym About the effect of intraoperative postural change on CVP and SVV
Scientific Title Effect of intraoperative repositioning on Central Venous Pressure (CVP) and Stroke Volume Variation (SVV)
Scientific Title:Acronym About the effect of intraoperative postural change on CVP and SVV
Region
Japan

Condition
Condition Patients who underwent hepatectomy
Classification by specialty
Surgery in general Hepato-biliary-pancreatic surgery Anesthesiology
Operative medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clarify the degree of influence (whether or not there is a correlation between the rate of change of CVP value and SVV value) on the fluctuation of CVP value and SVV value due to postural change performed during hepatectomy.
Clarify whether SVV can be used as an alternative index of CVP and whether the fluctuation range of CVP due to postural change can be predicted from SVV.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes With 0 degree as the reference value, evaluate the correlation between the rate of change of CVP and SVV due to intraoperative postural change (5 degree and 10 degree ) using linear regression analysis.
Key secondary outcomes If the SVV value does not show a large change due to the postural change, the estimation of the CVP change rate in the SVV eigenvalue and the identification of the factors that influence the change due to the postural change of CVP / SVV are verified as secondary evaluation items. In the statistical analysis method, regarding the estimation of the CVP change rate in the SVV eigenvalue, the CVP change rate in the SVV value for each case is obtained, evaluated by performing linear regression analysis, and the factors that influence the fluctuation due to the position change of CVP / SVV. Identification is evaluated by performing multivariate analysis using preoperative information or information obtained during surgery as explanatory variables.

Base
Study type Interventional

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
Maneuver
Interventions/Control_1 Postural change during hepatectomy
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 1: Patients who undergo hepatectomy as scheduled surgery (no provisions are made based on age, gender, target disease, or presence or absence of prior treatment)
2: Patients in whom a central venous catheter capable of CVP measurement is inserted and indwelled during surgery, and a Flo TracTM Sensor is connected to the arterial indwelling catheter so that SVV can be calculated.
3: Patients aged 20 years or older at the time of consent acquisition.
4: Patients who received sufficient explanation and fully understood when participating in this study, and obtained written consent by the patient himself / herself.
Key exclusion criteria 1: Patients with unstable hemodynamics at the time of induction of anesthesia (shock index> 1)
2: Patients with severe aortic regurgitation or atrial fibrillation (because the analysis result by Flo TracTM Sensor becomes unstable)
3: Patients judged by the investigator to be inappropriate as subjects
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Koizumi
Organization St. Marianna University Hospital
Division name Department of Gastroenterological and General Surgery
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-shi,Kanagawa pref, Japan
TEL 044-977-8111
Email satoshi.koizumi@marianna-u.ac.jp

Public contact
Name of contact person
1st name Akiyoshi
Middle name
Last name Masuda
Organization St. Marianna University Hospital
Division name Department of Gastroenterological and General Surgery
Zip code 216-8511
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-shi,Kanagawa pref, Japan
TEL 044-977-8111
Homepage URL
Email akiyoshi.masuda@marianna-u.ac.jp

Sponsor
Institute St. Marianna University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Board of St. Marianna University Hospital
Address 2-16-1, Sugao, Miyamae-ku, Kawasaki-shi,Kanagawa pref, Japan
Tel 044-977-8111
Email k-sienbu.mail@marianna-u.ac.jp

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
2021 Year 05 Month 17 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 Open public recruiting
Date of protocol fixation
2020 Year 11 Month 25 Day
Date of IRB
2020 Year 11 Month 25 Day
Anticipated trial start date
2020 Year 11 Month 25 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 04 Month 22 Day
Last modified on
2021 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050262

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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