UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033461 |
|---|---|
| Receipt number | 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 | 2022/09/13 14:26:36 |
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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 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
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
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
kmizunoya201331@gmail.com
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037873
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
