UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020991 |
|---|---|
| Receipt number | R000024212 |
| Scientific Title | Intraoperative glycemic control using artificial pancreas in cardiovascular surgery |
| Date of disclosure of the study information | 2016/02/18 |
| Last modified on | 2017/08/16 18:16:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intraoperative glycemic control using artificial pancreas in cardiovascular surgery
Acronym
Intraoperative glycemic control using artificial pancreas in cardiovascular surgery
Scientific Title
Intraoperative glycemic control using artificial pancreas in cardiovascular surgery
Scientific Title:Acronym
Intraoperative glycemic control using artificial pancreas in cardiovascular surgery
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate efficacy of artificial pancreas(STG-55, medical device) as glucose variability in cardiovascular surgery, safety of artificial pancreas as tight glycemic control.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Standard deviation of intraoperative glucose level as a index of glucose variability
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
| Medicine | Device,equipment |
Interventions/Control_1
We applied artificial pancreas to intraoperative glycemic control in cardiovascular surgery, as on a operation with cardiopulmonary bypass we used artificial pancreas from the beginning of cardiopulmonary bypass to the termination of it, as on a operation without cardiopulmonary bypass we used artificial pancreas from the beginning of operation to the end of it.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
･20-80 year-old adult patients
･Scheduled cardiovascular surgery patients
Key exclusion criteria
･Pregnacy, or pssibility of pregnacy patients
･Congenital metabolic disorder patients
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kinoshita Osamu |
Organization
The University of Tokyo Hospital
Division name
Cardiac surgery
Zip code
Address
Bunkyo-Ku Hongo 7-3-1, Tokyo, Japan
TEL
03-3815-5411
HOSHINOY-SUR@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hoshino Yasuhiro |
Organization
The University of Tokyo Hospital
Division name
Cardiac surgery
Zip code
Address
Bunkyo-ku Hongo 7-3-1, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
HOSHINOY-SUR@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
NIKKISO CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 02 | Month | 18 | 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
| 2016 | Year | 02 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 18 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 12 | Day |
Last modified on
| 2017 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024212
