UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013778 |
|---|---|
| Receipt number | R000016081 |
| Scientific Title | A trial of preoperative fluid and CHO-loading on catabolism in patients with general anesthesia. |
| Date of disclosure of the study information | 2014/05/01 |
| Last modified on | 2016/07/07 11:26:11 |
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Basic information
Public title
A trial of preoperative fluid and CHO-loading on catabolism in patients with general anesthesia.
Acronym
A trial of preoperative fluid and CHO-loading on catabolism in patients with general anesthesia.
Scientific Title
A trial of preoperative fluid and CHO-loading on catabolism in patients with general anesthesia.
Scientific Title:Acronym
A trial of preoperative fluid and CHO-loading on catabolism in patients with general anesthesia.
Region
| Japan |
Condition
Condition
inpatient
Classification by specialty
| Surgery in general | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Anesthesiology | Neurosurgery | Cardiovascular surgery |
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Whether preoperative fluid and CHO-loading induces protein catabolism?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose, 3-methyl-histidine, creatinine, fatty acid, prealbumin, insulin, ketone bodies
Key secondary outcomes
body water, REEs, RQ
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Drink Arginaid Water on Preoperation.
Interventions/Control_2
Drink clear fluid on Preoperation.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA Physical Status I-III
inpatients
Key exclusion criteria
ASA Physical Status IV
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Nakaya |
Organization
Sikoku Central Hospital
Division name
Division of Clinical Research
Zip code
Address
2233 Kawanoe Sikokutyuuou Ehime Japan
TEL
0896583515
nakaya.y@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Tsutsumi |
Organization
Tokushima University Hospital
Division name
Deptartment of Anesthesiology
Zip code
Address
3-18-15 Kuramoto Tokushima JAPAN
TEL
0886337181
Homepage URL
tsutsumi@tokushima-u.ac.jp
Sponsor or person
Institute
Sikoku Central Hospital
Institute
Department
Personal name
Funding Source
Organization
MEXT
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
| 2014 | Year | 05 | 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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | 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
| 2014 | Year | 04 | Month | 21 | Day |
Last modified on
| 2016 | Year | 07 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016081
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
