UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of energy consumption during abdominal surgery with metabolic monitor and investigation of fluid transfusion
Title of the study (Brief title)	Measurement of energy consumption during abdominal surgery with metabolic monitor and investigation of fluid transfusion Containing glucose or no glucose
Region	Japan

Condition
Condition	Patients undergoing abdominal surgery under general anesthesia
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Obsterics and gynecology Urology Anesthesiology Neurosurgery Operative medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Measure the amount of energy consumption during abdominal surgery using metabolic monitor and investigate the variation of energy consumption and the influence on glucose metabolism after surgery by infusing glucose containing fluid, not containg glucose or amino acid
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The amount of energy consumption during surgery blood concentration of ketone body blood concentration of lactate blood concentration of 3-methyl histidine blood concentration of free fatty acid
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Infuse acetate Ringer solution during general anesthesia
Interventions/Control_2	Infuse acetate Ringer solution containg 1% glucose during general anesthesia
Interventions/Control_3	Infuse amino acid fluid during general anesthesia
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	undergoing surgery under general anesthesia
Key exclusion criteria	ASA physical status >=3 neurologic disease, renal disorder, liver disorder,emaciation, morbid obesity,undergoing lapaloscopic surgery
Target sample size	300

Research contact person
Name of lead principal investigator	Narutomo Wakamatsu
Organization	Tokushima University
Division name	Department of Anesthesia
Address	50-1 2cho-me Kuramoto Town, Tokushima City,Tokushima
TEL
Email

Public contact
Name of contact person
Organization	Tokushima University
Division name	Department of Anesthesia
Address
TEL
Homepage URL
Email	narutomo@clin.med.tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Department of Anesthesia
Institute
Department

Funding Source
Organization	JSPS
Organization
Division
Category of Funding Organization
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	2011 Year 01 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 12 Month 01 Day
Anticipated trial start date	2011 Year 01 Month 01 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	2010 Year 12 Month 16 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005638