UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009330 |
|---|---|
| Receipt number | 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 20:12:25 |
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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
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
s.yoshimura0829@gmail.com
Sponsor or person
Institute
Department of Anesthesiology and Medical Crisis Management, Nagoya City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010951
