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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014598
Receipt No. R000016984
Scientific Title Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Date of disclosure of the study information 2014/07/22
Last modified on 2019/07/30

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Basic information
Public title Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Acronym Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Scientific Title Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Scientific Title:Acronym Study on glucose and amino acid level included in the infusion at the perioperative period of the gastrectomy
Region
Japan

Condition
Condition Gastric cancer
Classification by specialty
Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A purpose of this study is to clarify the influence that the vein nourishment management with glucose and the amino acid after the gastrectomy gives for patient recovery.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes urinary 3-methylhistidine as protein metabolism valuation.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is 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 Amino acid free arm (NPC/N ratio = 0)
Interventions/Control_2 Amino acid and glucose arm (NPC/N ratio = about 150)
Interventions/Control_3 Animo acid (NPC/N ratio = about 64)
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
25 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Planned gastrectomy patient
2.The patient that an agreement was provided in a document from the person before registration
3.Weight:45-70kg
4.ASAPS 1or2
Key exclusion criteria 1.Patient with the past of a coronary heart disease, the cerebrovascular disorde
2.Patient with a renal function disorder
3.Patient with the electrolyte abnormality
4.Patient with a Diabetic Miatus
5.Patient receiving the diuretic
6.Patient receiving the steroid
7.The patient who does central veins nourishment
8.Highly obese patient(BMI 35 over)
9.Thin patient(BMI 17.5 under)
10.the pregnant
11.Patient with the remote metastasis
12.The patient who enforces medical treatment in preoperation
13.Patient with weight losses more than 10% of in preoperation within six months
14.Patient considered to be inappropriate as an object of this study by the judgment of the doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Hiroya
Middle name
Last name Takeuchi
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code 160-8582
Address Tokyo to sinnjuku ku sinanomachi 35
TEL 03-3353-1211
Email htakeuch@sc.itc.keio.ac.jp

Public contact
Name of contact person
1st name Kazumasa
Middle name
Last name Fukuda
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code 160-8582
Address Tokyo to sinnjuku ku sinanomachi 35
TEL 03-3353-1211
Homepage URL
Email fukudak@z6.keio.jp

Sponsor
Institute Department of Surgery, School of Medicine, Keio University
Institute
Department

Funding Source
Organization Department of Surgery, School of Medicine, Keio University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine, Ethics Committee
Address Tokyo to sinnjuku ku sinanomachi 35
Tel 03-5363-3503
Email med-rinri-jimu@adst.keio.ac.jp

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 07 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 07 Month 29 Day
Date of IRB
2011 Year 07 Month 29 Day
Anticipated trial start date
2011 Year 10 Month 30 Day
Last follow-up date
2017 Year 03 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 07 Month 20 Day
Last modified on
2019 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016984

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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