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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name