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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004739
Receipt No. R000005638
Scientific Title Measurement of energy consumption during abdominal surgery with metabolic monitor and investigation of fluid transfusion
Date of disclosure of the study information 2011/01/06
Last modified on 2017/01/05

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Basic information
Public title Measurement of energy consumption during abdominal surgery with metabolic monitor and investigation of fluid transfusion
Acronym Measurement of energy consumption during abdominal surgery with metabolic monitor and investigation of fluid transfusion
Containing glucose or no glucose
Scientific Title Measurement of energy consumption during abdominal surgery with metabolic monitor and investigation of fluid transfusion
Scientific Title:Acronym 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
1st name
Middle name
Last name Narutomo Wakamatsu
Organization Tokushima University
Division name Department of Anesthesia
Zip code
Address 50-1 2cho-me Kuramoto Town, Tokushima City,Tokushima
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima University
Division name Department of Anesthesia
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 06 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 Completed
Date of protocol fixation
2010 Year 12 Month 01 Day
Date of IRB
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

Other
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

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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