UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014598 |
|---|---|
| Receipt number | 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 15:55:38 |
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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
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
fukudak@z6.keio.jp
Sponsor or person
Institute
Department of Surgery, School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016984
