UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008679 |
|---|---|
| Receipt number | R000010198 |
| Scientific Title | Clinical analysis about efficacy of Amino acids for metabolism during surgery |
| Date of disclosure of the study information | 2012/08/15 |
| Last modified on | 2015/04/04 20:24:25 |
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Basic information
Public title
Clinical analysis about efficacy of Amino acids for metabolism during surgery
Acronym
Clinical analysis about efficacy of Amino acids for metabolism during surgery
Scientific Title
Clinical analysis about efficacy of Amino acids for metabolism during surgery
Scientific Title:Acronym
Clinical analysis about efficacy of Amino acids for metabolism during surgery
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy of amino acid for metabolism during surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
3-Methyl Histidine
Key secondary outcomes
respiratory quotient
blood glucose
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Amino Acids group; Infusion of Amino Acids solution 500ml during surgery (80ml/hr)
Interventions/Control_2
Controlgroup; Infusion of acetate ringer solution with 1% glucose 500ml during surgery (80ml/hr)
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
The patients who will undergo gastrostomy for gastric cancer.
Key exclusion criteria
Diabetes (HbA1c>7.4%)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masataka Yokoyama |
Organization
Kochi Medical School
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Yatabe |
Organization
Kochi Medical School
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Kochi Medical School,Department of Anesthesiology and Intensive Care Medicine
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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 20 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2015 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010198
