Effect of glycemic control by insulin sliding scale protocol versus continuous insulin infusion on malondialdehyde (MDA) and protein carbonyl (PCO) in non-diabetic hyperglycemia patients in ICU
The purpose of this study is to compare the effect of blood glucose (BG) control by Continuous Insulin Infusion (CII) and Insulin Sliding Scale (ISS) on malondialdehyde (MDA) and protein carbonyl as oxidative stress biomarkers in non-diabetic ICU patients.
In this prospective, randomized clinical trial, 60 adult non-diabetic patients with stress induced hyperglycemia, defined as BG>180mg/dL, will be recruited from ICU of Imam Hossein Hospital, Tehran, Iran. Patients will be entered to CII and ISS groups, randomly. In CII group the insulin infusion rate will be determined by BG level based on institutional protocol. The target of BG is 140-180mg/dL in both groups and the duration of the study is 7 days. Beside clinical data, MDA and PCO levels will be determined at baseline, 3rd and 7th days of the study. Primary outcome measures are comparison of MDA and PCO and their changes in two group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014050810178N6
Registration date:2014-06-01, 1393/03/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-01, 1393/03/11
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2014-01-20, 1392/10/30
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of glycemic control by insulin sliding scale protocol versus continuous insulin infusion on malondialdehyde (MDA) and protein carbonyl (PCO) in non-diabetic hyperglycemia patients in ICU
Public title
Blood glucose control in ICU: insulin sliding scale versus continuous insulin infusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Blood glucose more than 180 mg/dL in ICU
2) No diabetes history
3) At least 18 years old
Exclusion criteria:
1) Less than 18 years old
2) Diabetes diagnosis during the study
3) Lack of patient or patient's relatives Consent
4) Transport to other units or death within 8 days of entrance
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
SBMU Medical Ethics and Law Research Center
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Postal code
Approval date
2012-09-16, 1391/06/26
Ethics committee reference number
8283/400
Health conditions studied
1
Description of health condition studied
stress hyperglycemia
ICD-10 code
R73.9
ICD-10 code description
Hyperglycaemia, unspecified
Primary outcomes
1
Description
Malondialdehyde (MDA)
Timepoint
Baseline, 3rd and 7th days of study
Method of measurement
Biochemistry
2
Description
Protein Carbonyl (PCO)
Timepoint
Baseline, 3rd and 7th days of study
Method of measurement
Biochemistry
Secondary outcomes
1
Description
Sequential Organ Failure Assessment (SOFA)
Timepoint
Daily
Method of measurement
Scoring system (consists of 6 scoring criteria)
2
Description
ICU stay
Timepoint
Daily
Method of measurement
Days
3
Description
Daily insulin requirement
Timepoint
Daily
Method of measurement
Insulin unit
4
Description
Blood glucose
Timepoint
Daily average
Method of measurement
Every hour to every six hour, mg/dL
Intervention groups
1
Description
Control group: BG control by Insulin Sliding Scale
Intervention group: BG control by Continuous Insulin Infusion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ICU, Imam Hossein Hospital
Full name of responsible person
Mohammad Sistanizad, Pharm. D., Clinical Pharmacy Specialist, Assistant Professor
Street address
Shaheed Madani St., Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Shams
Street address
Velenjak St., Shahid Chamran Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
+98 21 8820 0087
Fax
Email
sistanizadm@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Rastin
Position
Pharmacy doctorate / researcher
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)