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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025497
Receipt No. R000029093
Scientific Title Clinical exploratory study on the usefulness of hemodynamic preloading parameters using noninvasive cardiac output measuring device (ClearSight) for perioperative fluid management
Date of disclosure of the study information 2017/01/04
Last modified on 2017/07/04

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Basic information
Public title Clinical exploratory study on the usefulness of hemodynamic preloading parameters using noninvasive cardiac output measuring device (ClearSight) for perioperative fluid management
Acronym Clinical exploratory study on the usefulness of hemodynamic preloading parameters using noninvasive cardiac output measuring device
Scientific Title Clinical exploratory study on the usefulness of hemodynamic preloading parameters using noninvasive cardiac output measuring device (ClearSight) for perioperative fluid management
Scientific Title:Acronym 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
1st name
Middle name
Last name Kimitaka Tanaka
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological surgery II
Zip code
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
1st name
Middle name
Last name Kimitaka Tanaka
Organization Hokkaido University Graduate School of Medicine
Division name Gastroenterological surgery II
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2016 Year 12 Month 27 Day
Date of IRB
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

Other
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

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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