UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical exploratory study on the usefulness of hemodynamic preloading parameters using noninvasive cardiac output measuring device (ClearSight) for perioperative fluid management
Title of the study (Brief title)	Clinical exploratory study on the usefulness of hemodynamic preloading parameters using noninvasive cardiac output measuring device
Region	Japan

Condition
Condition	Biliary tumor, pancreatic tumor, and esophageal tumor
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	the effectiveness by investigating the correlation between hemodynamic parameters using the ClearSight system and existing parameters for perioperative fluid management was verified, and the safety of wearing the ClearSight system in perioperative patients was verified.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the correlation between the value of stroke volume variation measured by ClearSight and central venous pressure on the first postoperative day
Key secondary outcomes	1. the correlation between the value of stroke volume variation measured by ClearSight and central venous pressure on the second postoperative day 2. the correlation between the value of stroke volume variation measured by ClearSight and inferior vena cava diameter on the first or second postoperative day 3. change of the value of stroke volume variation between pre-infusion loading and post-infusion loading

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	1. Patients over 20 years of age 2.Patients with central venous catheter who undergo hepatectomy or pancreatectomy or esophagectomy expected for operation time of more than 6 hours in our department 3.Required written informed consent for participation
Key exclusion criteria	1. Patients with Peripheral Arterial Occlusive Disease 2. Patients with chronic arrhythmia 3. Patients with high risk of postoperative delirium 4. Investigator could exclude insufficient patients for this study
Target sample size	18

Research contact person
Name of lead principal investigator	Kimitaka Tanaka
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological surgery II
Address	North 15 West 7, Kita-ku, Sapporo city, Japan
TEL	011-716-1161
Email	kimitaka.t@gmail.com

Public contact
Name of contact person	Kimitaka Tanaka
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological surgery II
Address	North 15 West 7, Kita-ku, Sapporo city, Japan
TEL	011-716-1161
Homepage URL
Email	kimitaka.t@gmail.com

Sponsor
Institute	Hokkaido Universtiy Graduate School of Medicine, Department of Gastroenterological SurgeryII
Institute
Department

Funding Source
Organization	Hokkaido Universtiy Graduate School of Medicine, Department of Gastroenterological SurgeryII
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 01 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 27 Day
Anticipated trial start date	2017 Year 01 Month 06 Day
Last follow-up date
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	1. Patient's characteristics 2. Surgical Information 3. Information obtained from ClearSight 4. Central venous pressure and inferior vena cava diameter

Management information
Registered date	2017 Year 01 Month 02 Day
Last modified on	2017 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029093