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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036310
Receipt No. R000041335
Scientific Title Random test of Artificial pancreas machine in cardiovascular surgery field
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/27

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Basic information
Public title Random test of Artificial pancreas machine in cardiovascular surgery field
Acronym Random test of Artificial pancreas machine
Scientific Title Random test of Artificial pancreas machine in cardiovascular surgery field
Scientific Title:Acronym Random test of Artificial pancreas machine
Region
Japan

Condition
Condition Cardiovascular surgery disease
Classification by specialty
Anesthesiology Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To research safety and effectiveness prospectively of artificial pancreas machine on the cardiovascular surgery patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Morbidity of major complications, rate of surgical site infection, blood sample tests, higher brain function, delirium
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Strict Group: By using Artificial Pancreas Machine, Blood glucose is controlled between 90 - 100 mg/dL. Period: From anesthetic induction to 2POD.
Interventions/Control_2 Mild Group: By using Artificial Pancreas Machine, Blood glucose is controlled between145 - 155 mg/dL. Period: From anesthetic induction to 2POD.
Interventions/Control_3 Control, Manual Group: Without Artificial Pancreas Machine, Blood glucose is controlled according to a sliding scale in a traditional manner. Period: From anesthetic induction to 2POD.
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

Not applicable
Gender Male and Female
Key inclusion criteria All cardiovascular surgery patients of our Department, except emergent cases.
Key exclusion criteria Emergent cases.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Noboru
Middle name
Last name Motomura
Organization Toho University Sakura Medical Center
Division name Department of Cardiovascular Surgery
Zip code 285-8741
Address 564-1, Shimoshizu, Sakura-City, Chiba
TEL 043-462-8811
Email noboru@motomura.org

Public contact
Name of contact person
1st name Noboru
Middle name
Last name Motomura
Organization Toho University Sakura Medical Center
Division name Department of Cardiovascular Surgery
Zip code 285-8741
Address 564-1, Shimoshizu, Sakura-City, Chiba
TEL 043-462-8811
Homepage URL
Email noboru@motomura.org

Sponsor
Institute Toho University Sakura Medical Center, Department of Cardiovascular Surgery
Institute
Department

Funding Source
Organization Toho University Sakura Medical Center, Department of Cardiovascular Surgery
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Nil
Name of secondary funder(s)

IRB Contact (For public release)
Organization IRB of Toho University Sakura Medical Center
Address 564-1, Shimoshizu, Sakura-City, Chiba
Tel 043-462-8811
Email sakura.rinri@ext.toho-u.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
2019 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 31 Day
Date of IRB
2018 Year 11 Month 13 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 03 Month 27 Day
Last modified on
2019 Year 03 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041335

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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