UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031245
Receipt No. 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 2020/08/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Obsterics 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
Email 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/
Email ykotake@med.toho-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Toho University Ohashi Medical Center
Institute
Department

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
Email 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
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
2020 Year 09 Month 30 Day
Date analysis concluded
2021 Year 03 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
2020 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035673

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.