Hyperglycemia is associated with increased mortality and morbidity. Current evidence has controversies about Intensive Insulin Therapy (IIT) and its effect on reducing mortality in critically ill patients. In this trial we evaluated the effect of IIT on mortality and morbidity of critically ill patients. Sixty adult patients admitted to surgical intensive care unit will be enrolled in this study. Patients with ICU length of stay less than 3 days, DNR (do not resuscitate) order and ability to take oral feeding will be excluded. Patients will be randomly allocated to intensive insulin therapy group (with a target blood sugar of 80-120 mg/dl) and control group (receive insulin if blood glucose is more than 200 mg/dl). Study will be continued through the ICU stay of all patients. Mortality and Morbidity( Acute Kidney Injury, Renal Replacement Therapy, Bactremia, Hypoglycemia and transfusion requirements) of patients in two groups will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011062582N1
Registration date:2010-12-08, 1389/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-08, 1389/09/17
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
Tabriz University of Medical Sciences
Expected recruitment start date
2010-11-10, 1389/08/19
Expected recruitment end date
2011-11-10, 1390/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of insulin therapy on morbidity and mortality of critically ill patients admitted to intensive care unit
Public title
The effect of insulin therapy on outcome of critically ill patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: adult (more than 18 y.o) critically ill patients who admitted to surgical ICU (Intensive Care Unit). Exclusion criteria: Patients with Intensive Care Unit length of stay less than 3 days, patients who can tolerate oral feeding, patients with DNR (DO NOT RESSUSCITATE) order.
Creatinine increasing for Acute Kidney Injury, Number of packed cell which is transfused for transfusion requirement, positive blood culture and systemic inflammatory response syndrome for bacteremia, blood glucose less than 60 mg/dl as hypoglycemia
Intervention groups
1
Description
Intervention group will recieve insulin drip based on following formula: (BS-120) / 20. For hypoglycemic events insulin drip will be hold and patients will receive Dextrose Water 50% based on the formula: (100-BS)x0.4. Blood Sugar is measured every hour and during hypoglycemia each 30 minutes.
Category
Treatment - Drugs
2
Description
In Control group: patients receive bolus doses of insulin only in blood glucose more than 200 mg/dl based on the following formula: (BS-180)/30. Blood glucose will be monitored three times daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
General ICU of Shohada hospital
Full name of responsible person
Ata Mahmoodpoor
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Faculty of Health and Nutrition
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Alireza Ostadrahimi
Position
Assistant professor, PhD of nutrition
Other areas of specialty/work
Street address
Health& Nutrition Faculty, Tabriz University of Medical Sciences & Health Services
City
Tabriz
Postal code
Phone
+98 41 1335 7311
Fax
Email
aostadrahimi@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
Director of ICU/ Assistant professor/Fellowship of Critical Care Medicine
Other areas of specialty/work
Street address
General ICU, Shohada Hospital, El-Goli street
City
Tabriz
Postal code
Phone
+98 41 1385 1117
Fax
+98 41 1385 3171
Email
mahmoodpoora@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)