The Comparison of the effects of metformin and insulin in the treatment of hyperglycemia after coronary artery bypass surgery in non diabetic patients.
The purpose of this study is to compare the effect of metformin and insulin in the treatment of hyperglycemia after coronary artery bypass surgery in patients without diabetes. This research is a clinical trial. The study population is all the patients who will be undergone coronary artery bypass surgery in Kosar Hospital in Semnan. The main criterion for inclusion is having blood glucose higher than 150 mg/dl after coronary artery bypass surgery. The main criterion for exclusion is having a history of diabetes. The sample of 30 participants in each group and totally 60 people have been estimated. For this research, the patients’ blood glucose will be assessed and recorded one hour before entering the operating room and three hours after the surgery. If a patient’s postoperative blood glucose ishigher than 150 mg/dl,he will be enrolled. The table of random numbers will be used to place the patients in two groups of insulin and metformin. The patients who are placed in insulin group will receive continuous infusion insulin according to protocol of surgeons Thoracic Society (STS). The patients in metformingroup will receive a dose of 500 mg metformin tablet twice a day.In both groups, at first the patients’ blood glucose will be controlled and recorded per hour and after the stabilization of blood glucose, it will be done every six hours. Then the difference between the initial blood glucose and calculated blood glucose will be calculated after intervention in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072311399N2
Registration date:2015-08-04, 1394/05/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-08-04, 1394/05/13
Registrant information
Name
Abbasali Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3107 1082
Email address
ebrahimian.aa@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the effects of metformin and insulin in the treatment of hyperglycemia after coronary artery bypass surgery in non diabetic patients.
Public title
The Comparison of the effects of metformin and insulin in the treatment of hyperglycemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Glycosylated hemoglobin less than 7%; Blood glucose above 150 mg/dl; Elective coronary artery bypass surgery; Age between 35 to 75 years old; The use of cardiopulmonary bypass; Hemodynamically stable(BP>70 mmHg and PR between 50 and 110).
Exclusion criteria: History of diabetes; GFR less than 60%; life-threatening arrhythmias; Prolonged intubation; The use of inotropic agents for hemodynamic stability; Potassium level higher than 5.5 or less than 3.5 on admission in ICU; Metabolic acidosis lower than 7.25 or lactate level higher than 4.5 mg/dl or BE less than 6 mmo/L; Pao 2 less than 60 mm Hg; The patient is NPO
Age
From 35 years old to 75 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
Ethic committee of Semnan University Of Medical sience
Street address
Vice chancellor for research, Semnan University of Medical Sciences, Basij Blvd
City
Semnan
Postal code
Approval date
2015-07-28, 1394/05/06
Ethics committee reference number
IR.Semums.Rec.1394.69
Health conditions studied
1
Description of health condition studied
Hyperglycemia after coronary artery bypass surgery
ICD-10 code
197.1
ICD-10 code description
Other functional disturbances following cardiac surgery
2
Description of health condition studied
Hyperglycaemia
ICD-10 code
R73.9
ICD-10 code description
Hyperglycaemia, unspecified
Primary outcomes
1
Description
Blood Suger
Timepoint
Up to 6 hours after surgery each time and then every 6 hours
Method of measurement
Glucometer device
Secondary outcomes
1
Description
Lactat
Timepoint
Q 12 Hr
Method of measurement
Using of ABG machine
Intervention groups
1
Description
In the intervention group (1) or insulin group, patients will receive continuous insulin infusion according to the protocol of STS.After starting insulin infusion ,these patients’ blood glucose will be controlled per hour and according to their blood glucose level, the amount of insulin infusion will be continued.In this group blood glucose control interval will be every six hours after the stabilization of blood glucose. Then insulin infusion and six-hour blood glucose control will continue until the end of the third postoperative day (72 hours).
Category
Treatment - Drugs
2
Description
In the intervention group (2) or metformin group, the patients will receive metformin 500 mg twice a day and before the next dose of metformin, their blood glucose will be evaluated. If lactate is higher than 4/5 or 2 mmol higher than the previous response, takingmetformin will be stopped and the patient will be excluded.In these patients after starting metformintablet, their blood glucose will be controlled per hour and it will continue until the stabilization of blood glucose level.In this group the blood glucose interval control will be every six hours after the stabilization of blood glucose. Then, the prescription of metformin tablet of a dose of 500 mg twice a day and six-hour control of blood glucose until the end of the third postoperative day (72 hours) will continue.