UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013259 |
|---|---|
| Receipt number | R000015468 |
| Scientific Title | Examination for glucose metabolism with low glucose dosage infusion in perioperative appendectomy with infant and children |
| Date of disclosure of the study information | 2014/03/15 |
| Last modified on | 2019/08/22 18:02:08 |
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Basic information
Public title
Examination for glucose metabolism with low glucose dosage infusion in perioperative appendectomy with infant and children
Acronym
Examination of low glucose dosage infusion in perioperative appendectomy with children
Scientific Title
Examination for glucose metabolism with low glucose dosage infusion in perioperative appendectomy with infant and children
Scientific Title:Acronym
Examination of low glucose dosage infusion in perioperative appendectomy with children
Region
| Japan |
Condition
Condition
acute appendicitis
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine for glucose metabolism with low glucose dosage infusion in peritoneal appendectomy with infant and children
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
ketone body level(total ketone body level, 3-hydroxybutyric acid)
Key secondary outcomes
albumin level
post operative complication in early stage
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Extracellular fluid with low glucose dosage is infused from admission hospital to appendectomy
Interventions/Control_2
Extracellular fluid without low glucose dosage is infused from admission hospital to appendectomy
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
| Not applicable |
Age-upper limit
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Under 16 year's old
2) The patient who had a diagnosis of appendicitis
3) The patient who plans an appendectomy
4) The patient or protector have an agreement by the free will is provided after performing a document and oral enough explanation about the participation of this study
Key exclusion criteria
1)Patient during take with contraindicated medicine
2)Patient with liver , renaland heart complication
3)Patient with a serious side effect with these infusion in the past
4)Contraindicated Ppatient with these infusion
5)The pregnancy and the girl with nursing
6)The other reason, the chief physician assess to carry out the study inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Komura |
Organization
Saitama Medical University
Division name
Department of Pediatrics Surgery
Zip code
Address
Morohongou 38 Moroyamasho Irumagun Saitama
TEL
049-276-2116
komura-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke Satake |
Organization
Saitama Medical University
Division name
Department of Pediatrics Surgery
Zip code
Address
Morohongou 38 Moroyamasho Irumagun Saitama
TEL
049-276-1654
Homepage URL
ryonojiped@gmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical 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
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 | 03 | 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
| 2014 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 22 | 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 | 02 | Month | 25 | Day |
Last modified on
| 2019 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015468
