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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013259
Receipt No. 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

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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
Email 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
Email ryonojiped@gmail.com

Sponsor
Institute Saitama Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015468

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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