The aim of this randomized double-blind clinical trial was to evaluate metformin induced lactic acidosis in Type 2 Diabetic Patients after CABG Surgery in open heart ICU of Mazandaran Heart Center. A total of 200 patients, meeting eligibility criteria, were randomly allocated into the two equal groups. Three hours after extubation, the patients in the control group received regular insulin infusion according to the center protocol, as well as two placebo tablet every 12 hours and in the in the intervention group received regular insulin infusion according to the center protocol, as well as two 500 mg metformin tablets every 12 hours. Lactate, PH, BE and BS levels were measured every two hours and creatinine was measured every 6 hours and compared between groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008084365N4
Registration date:2011-01-21, 1389/11/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-21, 1389/11/01
Registrant information
Name
Afshin Gholipour Baradari
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 1245
Email address
gholipourafshin@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of metformin induced lactic acidosis in Type 2 Diabetic Patients after CABG Surgery
Public title
Evaluation of metformin induced lactic acidosis in Type 2 Diabetic Patients after CABG Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Informed written consent, Elective CABG surgery, Type 2 diabetes, Age between 35 and 75 years, Use of the cardiopulmonary pump during surgery, Hemodynamic stability (MAP> 60, absence of dangerous dysrhythmia or heart rate between 50-11)
Exclusion criteria: Liver dysfunction (SGPT and SGOT greater than 75), Renal dysfunction (serum creatinine greater than 1.5 in two consecutive tests), Heart failure (ejection fraction less than 30 percent), Serum lactate greater than 5mmo /l or increased more than 2mmol /l, Serum PH less than 7.25 or BE less than 6 mmol /l, Arterial oxygen partial pressure less than 60 mm Hg in two consecutive ABG, Use of contrast or angiography during two days before surgery, Potassium less than 3 meq/L, Nausea and vomiting, Use of metformin metabolism Inhibitor drugs such as amiodarone and cimetidine, Use of high dose inotropes more than three hours after extubation, Prolonged intubation (more than 6 hours after surgery), Need for reoperation for any reason
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:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences
Street address
Moallem Square
City
Sari
Postal code
46175866
Approval date
2011-01-05, 1389/10/15
Ethics committee reference number
89-126
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.7
ICD-10 code description
Non-insulin dependent diabetes mellitus
Primary outcomes
1
Description
lactate
Timepoint
every 2 hours
Method of measurement
mg/dl , Laboratory kit
Secondary outcomes
1
Description
Blood suger
Timepoint
every 2 hours
Method of measurement
mg/dl , Laboratory kit
2
Description
PH
Timepoint
every 2 hours
Method of measurement
Laboratory kit
3
Description
Base exess
Timepoint
every 2 hours
Method of measurement
mmol/l, Laboratory kit
4
Description
Creatinine
Timepoint
every 6 hours
Method of measurement
mg/dl , Laboratory kit
5
Description
Potassium serum level
Timepoint
Every 6 hours
Method of measurement
laboratory test
Intervention groups
1
Description
Control group: regular insulin infusion according to the center protocol, as well as two placebo tablet every 12 hours
Category
Placebo
2
Description
Intervention group: regular insulin infusion according to the center protocol, as well as two 500 mg metformin tablets every 12 hours
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mazandaran heart center
Full name of responsible person
Rahman Ghafari- MD-cardiac surgen- Assistant Professor
Street address
Artesh Blvd
City
sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati MD
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University Of Medical Sciences
Full name of responsible person
Hadi Darvishi Khezri
Position
MSc of Critical care nursing-Nurse of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square
City
Sari
Postal code
48175-866
Phone
+98 15132612458
Fax
+98 15 1326 2679
Email
hadidarvishi87@yahoo.com
Web page address
www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University Of Medical Sciences
Full name of responsible person
Afshin Gholipour Baradari MD
Position
CCMF- Assistant Professor-Chief of ICU
Other areas of specialty/work
Street address
Mazandaran University of Medical Sciences, Moallem Square