UMIN-CTR Clinical Trial

Basic information
Public title	The impact of fluid restriction by using stroke volume variation monitoring in the hepato-biliary-pancreatic operation: a single center, open label, randomized trial.
Acronym	The impact of fluid restriction by using stroke volume variation monitoring
Scientific Title	The impact of fluid restriction by using stroke volume variation monitoring in the hepato-biliary-pancreatic operation: a single center, open label, randomized trial.
Scientific Title:Acronym	The impact of fluid restriction by using stroke volume variation monitoring
Region	Japan

Condition
Condition	Hepato-biliary-pancreatic diseases which need operation for treatment
Classification by specialty	Hepato-biliary-pancreatic surgery Anesthesiology Operative medicine Intensive care medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The impact of fluid restriction by using stroke volume variation monitoring
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In-out balance during operation divided body weight and time of operation(ml/kg/hr)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Not Adding SVV monitoring in the anesthetic management of Hepato-biliary-pancreatic operation during operation
Interventions/Control_2	Adding SVV monitoring in the anesthetic management of Hepato-biliary-pancreatic operations during operation
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	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	The patients who take scheduled Hepatic-biliary-panratic operation and admit to SICU or ICU after operation
Key exclusion criteria	Patients who take only gallbladder resection Hb<7.0mg/dl Alb<2.0g/dl Patients who have atrial fibrilliation Patients who undergo dialysis Patients who don't get their consent
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yoshihumi Middle name Last name Kumada
Organization	Ohta Nishinouchi Hospital
Division name	Department of Anesthesiology and Emergency Medicine
Zip code	9638558
Address	2-5-20 Nishinouchi, Koriyama, Fukushima, Japan
TEL	+81-024-925-1188
Email	yk60@ohta-hp.or.jp

Public contact
Name of contact person	1st name Yudai Middle name Last name Iwasaki
Organization	Ohta Nishinouchi Hospital
Division name	Department of Anesthesiology and Emergency Medicine
Zip code	963-8558
Address	2-5-20 Nishinouchi, Koriyama, Fukushima 963-8558, Japan
TEL	+81-024-925-1188
Homepage URL
Email	yudai.i0213@gmail.com

Sponsor
Institute	Ohta Nishinouchi Hospital, Department of Anesthesiology and Emergency Medicine
Institute
Department

Funding Source
Organization	Ohta Nishinouchi Hospital, Department of Anesthesiology and Emergency Medicine
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	research ethnic committee of Ohta Nishinouchi Hospital
Address	2-5-20 Nishinouchi, Koriyama, Fukushima 963-8558, Japan
Tel	+81-024-925-1188
Email	nishinouchi@ohta-hp.or.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	2015 Year 06 Month 26 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	2015 Year 05 Month 30 Day
Date of IRB	2015 Year 05 Month 26 Day
Anticipated trial start date	2015 Year 06 Month 24 Day
Last follow-up date	2017 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	2015 Year 06 Month 26 Day
Last modified on	2019 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020967