The effects of glucose–insulin–potassium (GIK) in the treatment of ST segment elevation myocardial infarction (STEMI) are controversial.Hence we assess this effect of GIK in STEMI patients treated with streptokinase.
On admission, patients will randomly assign to GIK group or control group.In GIK group, GIK ( 25% glucose, 50 IU of soluble insulin per liter, and 80 mmol of potassium chloride per liter) will infuse at 1.5 ml/kg/hour in addition to 1.5 MU of streptokinase/30 to 60 minutes. In control group 1 L normal saline will infuse at 60 mL/h in addition to streptokinase. In each patient, total CK and CK-MB and troponin I level will measure on admission, 16 and24 hours thereafter.CRP will be checked in 0,6,24 and 48 hours there after. In all patients, plasma concentrations of glucose and potassium will determine before and at 6 hour after administering therapy.
An ECG will obtain at baseline and after 1 hour and a physician notes arrhythmia.
General information
Acronym
GIK
IRCT registration information
IRCT registration number:IRCT138804302210N1
Registration date:2010-06-06, 1389/03/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-06, 1389/03/16
Registrant information
Name
Maryam Hashemian
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 57 1444 6070
Email address
medical-school@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar university of medical science
Expected recruitment start date
2008-09-22, 1387/07/01
Expected recruitment end date
2009-07-23, 1388/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Glucose-Insulin-Potassium on patients with Acute ST-Segment-Elevation Myocardial Infarction
Public title
Effect of Glucose-Insulin-Potassium on patients with Acute ST-Segment-Elevation Myocardial Infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:All consecutive patients who had 20 minutes chest pain or its equivalent, time from symptom onset <12 hours, and had ST elevation ≥1 mm in ≥2 contiguous electrocardiographic leads when admitted to the Coronary Care Unit of the vaseie general hospital (Sabzevar ,Iran) were recruited.
Exclusion: Patient with systemic infection, glucocorticoid therapy, hypo tension, congestive heart failure, creatinine >2.0 mg/dL and anemia (hemoglobin <11 g/dL), were excluded. Further exclusion criteria were unwillingness to participate.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar university of medical science
Street address
Sabzevar university of medical science-Tehran road
City
Sabzevar
Postal code
9613873136
Approval date
2008-03-11, 1386/12/21
Ethics committee reference number
386010118
Health conditions studied
1
Description of health condition studied
Patients with ST elevation myocardial infarction
ICD-10 code
I21
ICD-10 code description
Acute myocardial infarction
Primary outcomes
1
Description
Plasma CRP level in the control and GIK groups
Timepoint
0, 6, 24 and 48 hours after admission
Method of measurement
ELIZA kit
Secondary outcomes
1
Description
Plasma CK and CK-MB and cardiac troponin I concentrations
Timepoint
0, 16 and 24 hours after admission
Method of measurement
ELIZA kit
2
Description
ST-segment resolution
Timepoint
60 minutes after thrombolytic therapy
Method of measurement
ECG
3
Description
Pain
Timepoint
0,1 and 2 hours after thrombolytic therapy
Method of measurement
Interview
4
Description
Arrythmia
Timepoint
7 days after admission
Method of measurement
Cardiac monitoring by a physician
5
Description
Re infarction
Timepoint
7 days after admission
Method of measurement
Recurrent ST elevation of 0.1 mv or recurrent increase in creatinin kinase MB
6
Description
Mortality
Timepoint
7 days after admission
Method of measurement
Any death when cardiac death could not be excluded
7
Description
Ejection fraction
Timepoint
72 hours after admission
Method of measurement
Echocardiography
Intervention groups
1
Description
Insulin Potassium Glucose ( 25% glucose, 50 IU of soluble insulin per liter, and 80 mmol of potassium chloride per liter) infused at 1.5 ml/kg/hour to GIK group in addition to 1.5 MU of streptokinase in 30 to 60 minutes
Category
Treatment - Drugs
2
Description
1 L normal saline at 60 mL/h in addition to streptokinase(1.5 MU in 30-60 minuts) infused to control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasseie educational hospital
Full name of responsible person
Maryam Hashemian
Street address
Tohidshahr road -Sabzevar
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar university of medical science
Full name of responsible person
Dr Peghan
Street address
Sabzevar university of medical science-Tehran road
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar university of medical science
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
Sabzevar university of medical science
Full name of responsible person
Maryam Hashemian
Position
MD
Other areas of specialty/work
Street address
Medical school-Tehran road
City
Sabzevar
Postal code
9613873136
Phone
+98 57 1444 6070
Fax
+98 57 1441 9573
Email
medical-school@medsab.ac.ir
Web page address
www.medsab.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar university of medical science
Full name of responsible person
Maryam Hashemian
Position
MD
Other areas of specialty/work
Street address
Medical school-Tehran road
City
Sabzevar
Postal code
9613873136
Phone
+98 57 1444 6070
Fax
+98 57 1441 9573
Email
hashemian3@yahoo.com
Web page address
www.medsab.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar university of medical science
Full name of responsible person
Maryam Hashemian
Position
M.D
Other areas of specialty/work
Street address
Medical school-Tehran road
City
Sabzevar
Postal code
9613873136
Phone
+98 57 1441 9574
Fax
+98 57 1441 9573
Email
hashemian3@yahoo.com
Web page address
www.medsab.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)