UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008832 |
|---|---|
| Receipt number | R000010366 |
| Scientific Title | Comparison of the use of bicarbonated Ringer's solution and acetated Ringer's solution in hepatic resection |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2022/09/16 09:26:43 |
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Basic information
Public title
Comparison of the use of bicarbonated Ringer's solution and acetated Ringer's solution in hepatic resection
Acronym
Comparison of the use of bicarbonated Ringer's solution and acetated Ringer's solution
Scientific Title
Comparison of the use of bicarbonated Ringer's solution and acetated Ringer's solution in hepatic resection
Scientific Title:Acronym
Comparison of the use of bicarbonated Ringer's solution and acetated Ringer's solution
Region
| Japan |
Condition
Condition
Patients scheduled for hepatic resection at Niigata University Medical and Dental Hospital
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of bicarbonated or acetated Ringer's solutions during hepatic resection surgery involving hepatic blood flow occlusion and the risk of bleeding;to evaluate the effect of bicarbonated Ringer's infusion on fluid, electrolyte, and acid-base balance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intraoperative acid-base balance
Key secondary outcomes
Intraoperative changes in bicarbonate, BE, lactate, arterial pH, Na +, K +, Cl-, blood glucose, Mg
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intraoperative infusion is performed by bicarbonated Ringer's solution
Interventions/Control_2
Intraoperative infusion in performed by acetated Ringer's solutionIntraoperative infusion in performed by acetated Ringer
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients scheduled for hepatic resection at Niigata University Medical and Dental Hospital
2.American Society of Anesthesiologists Physical Status Classification I-III
3.Patients who enter the operating room at 8:30 a.m.
4.Patients in whom epidural anesthesia can be performed
Key exclusion criteria
1.Patients who do not agree to participate
2.Patients in whom epidural anesthesia cannot be performed
3.Patients with cirrhosis
4.Patients in whom cardiac output and arterial blood pressure measuring device FloTracTM cannot be used
5.Patients with poorly controlled diabetes
6.Patients with severe renal dysfunction,hemodialysis patients
7.Patients requiring transfusion before entering the operating room
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Baba |
Organization
Niigata University Graduate School of Medical and Dental Science
Division name
Department of Anesthesiology
Zip code
Address
1-757, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
025-227-2328
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachiko Saji |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Anesthesiology
Zip code
Address
1-754, Asahimachi-dori Chuo-ku Niigata, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology,Niigata University Medical & Dental 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
新潟大学医歯学総合病院麻酔科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 02 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 02 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 31 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010366
