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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008679
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kochi Medical School,Department of Anesthesiology and Intensive Care 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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010198

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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