UMIN-CTR Clinical Trial

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