UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018111 |
|---|---|
| Receipt number | R000020967 |
| Scientific Title | The impact of fluid restriction by using stroke volume variation monitoring in the hepato-biliary-pancreatic operation: a single center, open label, randomized trial. |
| Date of disclosure of the study information | 2015/06/26 |
| Last modified on | 2019/12/29 19:23:10 |
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Basic information
Public title
The impact of fluid restriction by using stroke volume variation monitoring in the hepato-biliary-pancreatic operation: a single center, open label, randomized trial.
Acronym
The impact of fluid restriction by using stroke volume variation monitoring
Scientific Title
The impact of fluid restriction by using stroke volume variation monitoring in the hepato-biliary-pancreatic operation: a single center, open label, randomized trial.
Scientific Title:Acronym
The impact of fluid restriction by using stroke volume variation monitoring
Region
| Japan |
Condition
Condition
Hepato-biliary-pancreatic diseases which need operation for treatment
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology | Operative medicine |
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The impact of fluid restriction by using stroke volume variation monitoring
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-out balance during operation divided body weight and time of operation(ml/kg/hr)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Not Adding SVV monitoring in the anesthetic management of Hepato-biliary-pancreatic operation during operation
Interventions/Control_2
Adding SVV monitoring in the anesthetic management of Hepato-biliary-pancreatic operations during operation
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who take scheduled Hepatic-biliary-panratic operation and admit to SICU or ICU after operation
Key exclusion criteria
Patients who take only gallbladder resection
Hb<7.0mg/dl
Alb<2.0g/dl
Patients who have atrial fibrilliation
Patients who undergo dialysis
Patients who don't get their consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yoshihumi |
| Middle name | |
| Last name | Kumada |
Organization
Ohta Nishinouchi Hospital
Division name
Department of Anesthesiology and Emergency Medicine
Zip code
9638558
Address
2-5-20 Nishinouchi, Koriyama, Fukushima, Japan
TEL
+81-024-925-1188
yk60@ohta-hp.or.jp
Public contact
Name of contact person
| 1st name | Yudai |
| Middle name | |
| Last name | Iwasaki |
Organization
Ohta Nishinouchi Hospital
Division name
Department of Anesthesiology and Emergency Medicine
Zip code
963-8558
Address
2-5-20 Nishinouchi, Koriyama, Fukushima 963-8558, Japan
TEL
+81-024-925-1188
Homepage URL
yudai.i0213@gmail.com
Sponsor or person
Institute
Ohta Nishinouchi Hospital, Department of Anesthesiology and Emergency Medicine
Institute
Department
Personal name
Funding Source
Organization
Ohta Nishinouchi Hospital, Department of Anesthesiology and Emergency 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
research ethnic committee of Ohta Nishinouchi Hospital
Address
2-5-20 Nishinouchi, Koriyama, Fukushima 963-8558, Japan
Tel
+81-024-925-1188
nishinouchi@ohta-hp.or.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
| 2015 | Year | 06 | Month | 26 | 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
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 26 | Day |
Last modified on
| 2019 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020967
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
