UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of different intraoperative infusion on acid-base balance
Title of the study (Brief title)	Influence of different intraoperative infusion on acid-base balance
Region	Japan

Condition
Condition	Neurosurgical disease
Classification by specialty	Anesthesiology Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will compare the effects of the three kinds of Ringer's clinically frequently used on acid base balance.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postoperative arterial blood gas analysis result
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	bicarbonate Ringer's solution from the introduction of anesthesia to the end of operation
Interventions/Control_2	acetate Ringer's solution from the introduction of anesthesia to the end of operation
Interventions/Control_3	lactated Ringer's solution from the introduction of anesthesia to the end of operation
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing neurosurgery Patients who have obtained written informed consent from the patient
Key exclusion criteria	Patients who can not communicate Cases judged inappropriate as subjects of this clinical trial by the research director / contributor
Target sample size	63

Research contact person
Name of lead principal investigator	Kumiko Tanabe
Organization	Gifu University hospital
Division name	Anesthesiology
Address	Yanagido 1-1 Gifu city Gifu prefecture
TEL	0582306404
Email	kumiko-t@m2.gyao.ne.jp

Public contact
Name of contact person	Hitomi Sakurai
Organization	Gifu Citizen's hospital
Division name	Anesthesiology
Address	Kashimatyou 7-1 Gifu city Gifu prefecture
TEL	0582511101
Homepage URL
Email	hito.maro2420@gmail.com

Sponsor
Institute	Gifu University 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)

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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 03 Day
Anticipated trial start date	2018 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 03 Month 20 Day
Last modified on	2018 Year 06 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036310