UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036310 |
|---|---|
| Receipt number | 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 | 2022/03/29 09:52:06 |
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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
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
noboru@motomura.org
Sponsor or person
Institute
Toho University Sakura Medical Center, Department of Cardiovascular Surgery
Institute
Department
Personal name
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
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
https://www.lab.toho-u.ac.jp/med/sakura/pv/cvs/
Publication of results
Unpublished
Result
URL related to results and publications
Not yet
Number of participants that the trial has enrolled
120
Results
No hypoglycemic injury was seen in all of the 3 groups.
Results date posted
| 2022 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
NP
Date of the first journal publication of results
Baseline Characteristics
Cardiovascular surgery patients
Participant flow
Details of the research is explained at the time of IC for the surgery.
Adverse events
Nothing so far.
Outcome measures
Glucose during and after the surgery.
Plan to share IPD
NP
IPD sharing Plan description
NP
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
| 2022 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041335
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
