UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004739 |
|---|---|
| Receipt number | 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 13:28:42 |
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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 |
| Obstetrics 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
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
narutomo@clin.med.tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Department of Anesthesia
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005638
