UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Shigeru Saito
Organization	Gunma university hospital
Division name	Intensive care unit
Address	3-39-15 Showa-machi Maebashi Gunma
TEL	027-220-7111
Email	shigerus@gunma-u.ac.jp

Public contact
Name of contact person	Akihiro Yanagisawa
Organization	Gunma university hospital
Division name	Intensive care unit
Address	3-39-15 Showa-machi Maebashi Gunma
TEL	027-220-7111
Homepage URL
Email	aki.yanagisawa@gmail.com

Sponsor
Institute	Gunma university
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016581