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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033461
Receipt No. R000037873
Scientific Title Microcirculatory alterations monitored by vascuar occlusion test and near-infrared spectroscopy in patients undergoing major abdominal surgery
Date of disclosure of the study information 2018/07/20
Last modified on 2018/11/26

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Basic information
Public title Microcirculatory alterations monitored by vascuar occlusion test and near-infrared spectroscopy in patients undergoing major abdominal surgery
Acronym Microcirculatory alterations monitored by VOT and NIRS in major abdominal surgery
Scientific Title Microcirculatory alterations monitored by vascuar occlusion test and near-infrared spectroscopy in patients undergoing major abdominal surgery
Scientific Title:Acronym Microcirculatory alterations monitored by VOT and NIRS in major abdominal surgery
Region
Japan

Condition
Condition hepato-pancreato-biliary surgery(scheduled operation time is 8 hours or more)
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the impact of abdominal major surgery on microcirculation assessed by means of the response of tissue oxygen satuation during vascular occlusion test
Basic objectives2 Others
Basic objectives -Others To evaluate the influence of microcirculatory alterations on postoperative outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of microcirculatory responsiveness before and after surgery
Key secondary outcomes The relation between microcirculatory responsiveness and intraoperative hemodynamic variables
The relation between microcirculatory responsiveness and postoperative morbidity and prognosis within 30 days

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 The patients who have elective hepato-pancreato-biliary surgery (scheduled operation time is 8 hours or more) at Hokkaido university hospital department of gastroenterological surgery 2
Key exclusion criteria Patients who have peripheral vascular disease
NYHA functional class 2,3,or 4
Thoracic or abdominal aortic aneurysm
Chronic kidney disease on hemodialysis
The case we found not appropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Morimoto
Organization Hokkaido University Hospital
Division name Department of anesthesiology
Zip code
Address N14 W5, kita-ku, Sapporo
TEL 011-716-1161
Email morim2@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyuki Mizunoya
Organization Hokkaido University Hospital
Division name Department of anesthesiology
Zip code
Address N14 W5, kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email kmizunoya201331@gmail.com

Sponsor
Institute Hokkaido university hospital
Institute
Department

Funding Source
Organization None
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
2018 Year 07 Month 20 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Tissue oxygen satuation measurment by near-infrared spectroscopy during vascular occlusion test was reported as a non-invasive evaluation tool of microvascular responsiveness.
In this study, reperfusion rates of tissue oxygen saturation during vascular occlusion test before and after major abdominal surgery were compared. Futhermore, the relationship between oxygen reperfusion rate and systemic hemodynamic variables (blood pressure, cardiac output, etc) and postoperative complications were investigated.

Management information
Registered date
2018 Year 07 Month 20 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037873

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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