UMIN-CTR Clinical Trial

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