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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007094
Receipt No. R000008326
Scientific Title Efficacy of glucose infusion for the inhibition of breakdown of fat tissue and muscle protein under anesthesia
Date of disclosure of the study information 2012/02/01
Last modified on 2015/01/18

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Basic information
Public title Efficacy of glucose infusion for the inhibition of breakdown of fat tissue and muscle protein under anesthesia
Acronym Efficacy of glucose infusion for the inhibition of breakdown of fat tissue and muscle protein under anesthesia
Scientific Title Efficacy of glucose infusion for the inhibition of breakdown of fat tissue and muscle protein under anesthesia
Scientific Title:Acronym Efficacy of glucose infusion for the inhibition of breakdown of fat tissue and muscle protein under anesthesia
Region
Japan

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

Objectives
Narrative objectives1 The efficacy of glucose infusion for the inhibition of breakdown of fat tissue and muscle protein under anesthesia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma concentrations of acetoacetic acid and 3-hydroxybutyrate acid and urine 3-methylhistidine/plasma creatinine
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Glucose was administered at the rate of 2mg/kg/min.
Interventions/Control_2 Glucose was not administered.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with ASA physical status 1 or 2
Key exclusion criteria Patients with endocrine disease or disorder of metabolism, patients with heart failure or renal failure
Target sample size 120

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Michiaki Yamakage
Organization Sapporo Medical University
Division name Department of Anesthesiology
Zip code
Address South 1 jo, West 16 cho-me, Chu-o-ku, Sapporo, Hokkaido
TEL
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Atsushi Sawada
Organization Sapporo Medical University
Division name Department of Anesthesiology
Zip code
Address
TEL 011-611-2111
Homepage URL
Email

Sponsor
Institute Department of Anesthesiology, Sapporo Medical University School of Medicine
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 02 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 Completed
Date of protocol fixation
2012 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2014 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 18 Day
Last modified on
2015 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008326

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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