UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027107
Receipt No. R000030261
Scientific Title Efficacy of continuous interstitial glucose monitoring in intraoperative glycemic control
Date of disclosure of the study information 2017/04/24
Last modified on 2017/11/24

* 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 Efficacy of continuous interstitial glucose monitoring in intraoperative glycemic control
Acronym Efficacy of continuous interstitial glucose monitoring in intraoperative glycemic control
Scientific Title Efficacy of continuous interstitial glucose monitoring in intraoperative glycemic control
Scientific Title:Acronym Efficacy of continuous interstitial glucose monitoring in 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
Middle name
Last name Ryo Wakabayashi
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2670
Email waka0924@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryo Wakabayashi
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2670
Homepage URL
Email waka0924@shinshu-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Hokushin General Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 信州大学医学部附属病院(長野県)
北信総合病院(長野県)

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
Anticipated trial start date
2017 Year 04 Month 24 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
2017 Year 04 Month 24 Day
Last modified on
2017 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030261

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.