UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012641 |
|---|---|
| Receipt number | R000014706 |
| Scientific Title | Effect of fluid management on hemodynamic changes during epidural anesthesia |
| Date of disclosure of the study information | 2014/01/08 |
| Last modified on | 2019/06/12 13:24:11 |
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Basic information
Public title
Effect of fluid management on hemodynamic changes during epidural anesthesia
Acronym
volume effect during epidural anesthesia
Scientific Title
Effect of fluid management on hemodynamic changes during epidural anesthesia
Scientific Title:Acronym
volume effect during epidural anesthesia
Region
| Japan |
Condition
Condition
abdominal surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigation of hemodynamic changes by fluid management during epidural anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
hemodynamic changes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
intravenous infusion after epidural anesthesia
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
ASA 1 or 2 abdominal surgery
Key exclusion criteria
above ASA 3
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City Yanagido 1-1
TEL
058-230-6404
kumiko-t@m2.gyao.ne.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Tanabe |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Anesthesiology and Pain Medicine
Zip code
501-1194
Address
Gifu City Yanagido 1-1
TEL
058-230-6404
Homepage URL
kumiko-t@m2.gyao.ne.jp
Sponsor or person
Institute
Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gifu University Graduate School of Medicine
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
Gifu University Graduate School of Medicine
Address
Yanagido 1-1, Gifu City
Tel
058-230-6404
kumiko-t@m2.gyao.ne.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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 08 | 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
hemodynamic paramaters were not significantly different between colloid and crystalloid infusion after epidural anesthesia.
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 01 | Day |
Other
Other related information
Patients are anesthetized by general anesthesia with epidural anesthesia. Hemodynamic changes are recorded.
Management information
Registered date
| 2013 | Year | 12 | Month | 20 | Day |
Last modified on
| 2019 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014706
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
