The aim of this study is to determine the effects of glargine insulin on glycemic control in critically ill patients admitted to intensive care unit. Eighty patients admitted to intensive care unit (Shohada Hospital - Imam Reza Hospital) will be enrolled in this study. Patients will be randomly divided into two groups. All patients who are treated with insulin and do not have sensitivity to insulin will be enrolled in the study. The control group will receive routine treatment for glycemic control that is regular insulin infusion. Intervention group will receive 10 units of glargine insulin in addition to the routine treatment. In this study, insulin will be administered in blood glucose more than 140 mg/dl. In septic patients, due to the risk of hypoglycemia, insulin will be administered in blood glucose more than 150 mg/dl. Blood glucose of the patients will be checked every hour and if 3 consecutive samples are in the target range, blood glucose measurements will be every 4 hours. For all patients, mean blood glucose level, mean daily consumption of regular insulin and hypoglycemia will be recorded. The primary outcome variable is blood glucose level and the secondary outcome variable is mortality.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608182582N14
Registration date:2016-11-07, 1395/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-07, 1395/08/17
Registrant information
Name
Ata Mahmoodpoor
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 914 116 0888
Email address
mahmoodpoora@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of glargine Insulin on glycemia control in critically ill patients admitted to intensive care unit
Public title
Effect of long-term Insulin on glycemia control in critically ill patients admitted to intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All admitted diabetic patients in ICU
Exclusion: age under 18 y/o; sensitivity to insulin
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street
City
Tabriz
Postal code
Approval date
2016-05-23, 1395/03/03
Ethics committee reference number
IR.TBZMED.REC.1395.159
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E10
ICD-10 code description
Insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Blood Glucose
Timepoint
every one hours
Method of measurement
Laboratory
Secondary outcomes
1
Description
Mortality
Timepoint
Daily
Method of measurement
counting
Intervention groups
1
Description
intervention group: patients will receive 10 IU Glargine daily in addition to regular insulin therapy, subcutaneously.
Category
Treatment - Drugs
2
Description
control group: All patients will receive routine regular insulin therapy which is Regular insulin infusion. The regular insulin (Actrapid HM, NOVO Nordisk, Denmark) will be infused via central vain catheter using a 50-ml syringe and infusion pump (Perfussor-FM pump, B Braun).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU of Emam Reza Hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
General ICU, Emam Reza Hospital
City
Tabriz
2
Recruitment center
Name of recruitment center
ICU of Shohada Hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
ICU, Shohada Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Afshin Ghalehgolab Behbahani
Street address
Tabriz University of Medical Sciences- Golgasht street
City
Tabriz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical sciences
Full name of responsible person
Abdolreza Naghizadeh
Position
Resident of Anaesthesiology
Other areas of specialty/work
Street address
Faculty of Medicine, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3333 8413
Fax
Email
abdolreza_naghizadeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ata Mahmoodpoor
Position
associate professor
Other areas of specialty/work
Street address
Faculty of Medicine, Daneshgah street
City
Tabriz
Postal code
Phone
+98 41 3334 1994
Fax
Email
mahmoodpoora@Tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abdolreza Naghizadeh
Position
Resident of Anaesthesiology
Other areas of specialty/work
Street address
Faculty of Medicine, Daneshgah street
City
Tabriz
Postal code
5167747899
Phone
+98 41 3333 8413
Fax
Email
abdolreza_naghizadeh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)