UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027107 |
|---|---|
| Receipt number | R000030261 |
| Scientific Title | Efficacy of subcutaneous continuous glucose monitoring on intraoperative glycemic control |
| Date of disclosure of the study information | 2017/04/24 |
| Last modified on | 2019/11/17 14:23:04 |
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Basic information
Public title
Efficacy of subcutaneous continuous glucose monitoring on intraoperative glycemic control
Acronym
Efficacy of subcutaneous continuous glucose monitoring on intraoperative glycemic control
Scientific Title
Efficacy of subcutaneous continuous glucose monitoring on intraoperative glycemic control
Scientific Title:Acronym
Efficacy of subcutaneous continuous glucose monitoring on intraoperative glycemic control
Region
| Japan |
Condition
Condition
Patients undergoing cardiovascular surgery using cardiopulmonary bypass
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of intraoperative subcutaneous continuous glucose monitoring system in patients undergoing cardiovascular surgery using cardiopulmonary bypass compared with standard care.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome is the difference in mean blood glucose concentration 120 minutes after detachment of cardiopulmonary bypass
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
For patients in the subcutaneous continuous glucose monitoring group, an updated glucose value was visible on screen every 5 minutes during surgery and was used to guide treatment.
Interventions/Control_2
For patients in the standard care group, the screen
was turned blank, arterial blood glucose concentration is measured every 60-120 minutes according to standard care.
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
Patients undergoing cardiovascular surgery using cardiopulmonary bypass
Key exclusion criteria
Having insulin allergy and a state of blood coagulation disorder
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Wakabayashi |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
waka0924@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Wakabayashi |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
Homepage URL
waka0924@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine, Department of Anesthesiology and Resuscitology
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine, Institutional Review Board
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-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
| 2017 | Year | 04 | Month | 24 | 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
| 2017 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2017 | Year | 07 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 24 | Day |
Last modified on
| 2019 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030261
| 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 |
