UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Continuous blood glucose monitoring by artificial pancreas in patients with intracranial hypertension
Title of the study (Brief title)	Blood Glucose Monitoring by Artificial Pancreas -Intracranial Hypertension (GMAP-IH)
Region	Japan

Condition
Condition	Patients having brain diseases (brain trauma, stroke, and brain tumor, etc.) suffers intracranial hypertension which requires emergency decompressive surgery.
Classification by specialty	Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study evaluates that continuous blood glucose monitoring predicts effects of decompression in emergency operations in patients with intracranial hypertension.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Correlation between glucose change and decompressive manuplation during surgery
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	During decompressive surgery blood glucose is continuously monitored by artificial pancreas. Blood is sampled at a 2mL/hr from peripheral vein.
Interventions/Control_2
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Unconscious (JCS 10-200) Tolerable for general anesthesia Men and women of 20 years of age or older Unnecessary of insulin treatment Informed consent written by legally acceptable representative
Key exclusion criteria	Necessary of insulin treatment Requirement of glucose administration before and during surgery Pregnant or lactating women and women of child bearing potential Patients judged by investigators ineligible for participation as study subjects for any other reason.
Target sample size	40

Research contact person
Name of lead principal investigator	Shin-Ichi Miyatake
Organization	Osaka Medical College
Division name	Neurosurgery
Address	2-7, Daigakumachi, Takatsuki, Osaka, 569-8686, Japan
TEL	072-683-1221
Email	neu070@poh.osaka-med.ac.jp

Public contact
Name of contact person	Motomasa Furuse
Organization	Osaka Medical College
Division name	Neurosurgery
Address	2-7, Daigakumachi, Takatsuki, Osaka, 569-8686, Japan
TEL	072-683-1221
Homepage URL
Email	neu054@poh.osaka-med.ac.jp

Sponsor
Institute	Department of Neurosurgery, Osaka Medical college
Institute
Department

Funding Source
Organization	ZENKYOREN (Natinal Mutual Insurance Federation of Agricultural Cooperatives)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Department of Neurosurgery, Osaka Medical College

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	大阪医科大学附属病院（大阪府） （Osaka Medical College Hospital)

Other administrative information
Date of disclosure of the study information	2013 Year 11 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 29 Day
Anticipated trial start date	2013 Year 11 Month 27 Day
Last follow-up date	2016 Year 10 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 05 Month 31 Day
Date analysis concluded	2017 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 11 Month 15 Day
Last modified on	2017 Year 02 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014369