UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003733 |
|---|---|
| Receipt number | R000004522 |
| Scientific Title | Automatic insulin therapy in critically ill patients; Randmized cross-over controlled study |
| Date of disclosure of the study information | 2010/06/15 |
| Last modified on | 2012/12/10 10:37:28 |
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Basic information
Public title
Automatic insulin therapy in critically ill patients; Randmized cross-over controlled study
Acronym
Automatic insulin therapy in critically ill patients
Scientific Title
Automatic insulin therapy in critically ill patients; Randmized cross-over controlled study
Scientific Title:Acronym
Automatic insulin therapy in critically ill patients
Region
| Japan |
Condition
Condition
Adult ICU patients expected to stay for more than 3 days and had acute hyperglycemia defined as >150 mg/dL
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of automatic insulin therapy using STG-22, especially on the incidence of hypoglycemia, the achievement of target glucose levels, glycemic variability and oxidative stress.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The achievement of target blood glucose levels.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Automatic insulin therapy using STG-22
Interventions/Control_2
Protocol based insulin therapy
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
Adult ICU patients
expected to stay in ICU for more than 3 days
glucose level>150mgdL
Key exclusion criteria
Prediagnosed diabetic melitus
Contraindication of insulin
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Moritoki Egi |
Organization
Okayama University Hospital
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
2-5-1 Shikata tyou Okayama city, Okayama, Japan 700-8558
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Okayama University Hospital
Division name
Department of Anesthesiology and Resuscitology
Zip code
Address
TEL
086-235-7778
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society of the Promotion of Science
Organization
Division
Category of Funding 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
| 2010 | Year | 06 | Month | 15 | 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
Completed
Date of protocol fixation
| 2009 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 10 | Day |
Last modified on
| 2012 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004522
| 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 |
