UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031245 |
|---|---|
| Receipt number | R000035673 |
| Scientific Title | Effects of intraoperative hemodynamic and fluid management on the autonomic nervous system: An observational study. |
| Date of disclosure of the study information | 2018/02/13 |
| Last modified on | 2025/02/20 12:51:54 |
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Basic information
Public title
Effects of intraoperative hemodynamic and fluid management on the autonomic nervous system: An observational study.
Acronym
Intraoperative fluid management and autonomic nervous system.
Scientific Title
Effects of intraoperative hemodynamic and fluid management on the autonomic nervous system: An observational study.
Scientific Title:Acronym
Intraoperative fluid management and autonomic nervous system.
Region
| Japan |
Condition
Condition
Intraperitoneal surgery
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
| Urology | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Quantitative assessment of surgical stress by non-invasive, continuous physiological parameter.
Basic objectives2
Others
Basic objectives -Others
Exploration about the relationship between therapeutic intervention and physiological signal.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraoperative autonomic nervous system activity caused by intraoperative hemodynamic and fluid management
Key secondary outcomes
Relationship between intraoperative autonomic nervous system activity and plasma concentration of stress hormone.
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
Undergoing elective surgery for the treatment of intraperitoneal malignancy with laparotomy
Expected duration more than 6 hours.
Indication of invasive blood pressure monitoring.
Normal sinus rhythm.
Key exclusion criteria
Pregnant
Pacemaker rhythm
With known factors which affect the accuracy of invasive blood pressure monitoring
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
1538515
Address
2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
ykotake@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshifumi |
| Middle name | |
| Last name | Kotake |
Organization
Toho University Ohashi Medical Center
Division name
Department of Anesthesiology
Zip code
1538515
Address
2-17-6 Ohashi, Meguro, Tokyo, Japan
TEL
03-3468-1251
Homepage URL
http://www.lab.toho-u.ac.jp/med/ohashi/anesth/
ykotake@med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board, Toho University Ohashi Medical Center
Address
2-22-36, Ohashi, Meguro, Tokyo
Tel
03-3468-1251
ohashi.rinri@ext.toho-u.ac.jp
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
東邦大学医療センター大橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 13 | 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
41
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 05 | Month | 31 | Day |
Other
Other related information
This observational study aims to evaluate the predictive ability of the autonomic nervous system activity as an indicator of the fluid challenge in patients undergoing major intraperitoneal surgery.
Management information
Registered date
| 2018 | Year | 02 | Month | 10 | Day |
Last modified on
| 2025 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035673
