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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009330
Receipt No. R000010951
Scientific Title The efficacy of intraoperative glucose administration: estimation of respiration quotient from Indirect calorimetry
Date of disclosure of the study information 2012/11/13
Last modified on 2018/05/20

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Basic information
Public title The efficacy of intraoperative glucose administration: estimation of respiration quotient from Indirect calorimetry
Acronym The efficacy of intraoperative glucose administration: estimation of respiration quotient from Indirect calorimetry
Scientific Title The efficacy of intraoperative glucose administration: estimation of respiration quotient from Indirect calorimetry
Scientific Title:Acronym The efficacy of intraoperative glucose administration: estimation of respiration quotient from Indirect calorimetry
Region
Japan

Condition
Condition Surgical disease
Classification by specialty
Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The efficacy of intraoperative glucose administration for inhibition of catabolization
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes respiration quotient measured from indirect calorimetry
Key secondary outcomes Plasma concentration of glucose, acetoacetic acid, 3-hydroxybutyrate acid, free fatty acid, catecholamine 3- fractionation, ACTH, cortisol and 3-methyl histidine

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 dextrose was administered at the rate of 0.07g/kg/hr under general anesthesia.
Interventions/Control_2 dextrose was administered at the rate of 0.14g/kg/hr under general anesthesia.
Interventions/Control_3 dextrose was not administered under 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
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria ASA physical status 1or2
Key exclusion criteria patients with endocrine disease or disorder of metabolism, heart failure or renal failure
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichiro Yoshimura
Organization Nagoya City University
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1-Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601, JAPAN
TEL 09045874090
Email s.yoshimura0829@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Yoshimura
Organization Nagoya City University
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1-Kawasumi, Mizuho-cho Mizuho-ku, Nagoya 467-8601, JAPAN
TEL 09045874090
Homepage URL
Email s.yoshimura0829@gmail.com

Sponsor
Institute Department of Anesthesiology and Medical Crisis Management, Nagoya City University
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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.hoajonline.com/jacs/2049-9752/6/1
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 Main results already published
Date of protocol fixation
2012 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 15 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 11 Month 13 Day
Last modified on
2018 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010951

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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