UMIN-CTR Clinical Trial

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 outcome assessed by POMS score.

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
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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
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IRB Contact (For public release)
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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
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Baseline Characteristics
Participant flow
Adverse events
Outcome measures
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IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 07 Month 01 Day
Date of IRB	2018 Year 10 Month 26 Day
Anticipated trial start date	2018 Year 11 Month 20 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry	2020 Year 01 Month 31 Day
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	2022 Year 09 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037873