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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008832
Receipt No. 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 2012/09/10

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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
Email

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
Email

Sponsor
Institute Department of Anesthesiology,Niigata University Medical & Dental Hospital
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2012 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 08 Month 31 Day
Last modified on
2012 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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