Determination of lactic acidosis associated with Metformin usage in patients with type 2 diabetes undergone coronary angiography
Design
Clinical trial has a control group, with parallel and randomized groups
Settings and conduct
In this study, which is performed at Rajaei Hospital in Karaj, we continue to prescribe metformin in the intervention group before coronary angiography and up to 48 hours after that, and their lactic acid and pH levels are monitored within 48 hours.In the control group, we discontinue metformin 48 hours after angiography and control their lactic acid and blood pH
Participants/Inclusion and exclusion criteria
Inclusion:1)Patient with type 2 diabetes with a history of metformin usage who has undergone coronary angiography 2)The GFR before angiography is equal to or greater than 60 ml per minute 3)Patient's systolic blood pressure is equal to or greater than 90 mm Hg 4)Serum creatinine levels before angiography are less than 1.49 mg in males and less than 1.40 mg / dL in females 5)The patient's plasma pH should be 7.45-7.35 before angiography
Exclusion:1)Critical physical condition requires immediate intervention
2)Failure to perform PH or creatinine sampling and lactate levels after angiography 3)Sepsis and other conditions that cause lactic acidosis
4)Discontinuation of metformin by the patient 5)Diarrhea, vomiting, and other conditions that predispose the patient to dehydration
6)Increase serum creatinine by more than 1.5 mg / dL
Intervention groups
Intervention group: We continue the metformin usage before the angiography till 48 hours after the angiography. During these 48 hours, we follow up the patients and measure their plasma lactic acid levels and blood pH
Control group: In these patients, we discontinue metformin usage up to 48 hours after angiography and control their lactic acid and blood pH
Main outcome variables
Lactic acidosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200201046329N1
Registration date:2020-05-02, 1399/02/13
Registration timing:retrospective
Last update:2020-05-02, 1399/02/13
Update count:0
Registration date
2020-05-02, 1399/02/13
Registrant information
Name
Mohamad Jalali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3452 4882
Email address
mdrjalali@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
2018-12-22, 1397/10/01
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-09-23, 1398/07/01
Scientific title
Assessment of lactic acidosis associated with Metformin useage in Diabetic patients undergoing coronary angiography
Public title
Assessment of lactic acidosis associated with Metformin usage
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with type 2 diabetes who has undergone coronary angiography
The GFR before angiography is equal to or greater than 60 ml per minute
Patient with diabetes with a history of metformin usage
Patient's Ejection Fraction is equal to or greater than 45%
Patient's systolic blood pressure is equal to or greater than 90 mm Hg
Serum creatinine levels before angiography are less than 1.49 mg in males and less than 1.40 mg / ml in females
The patient's plasma pH should be 7.45-7.35 before angiography
Exclusion criteria:
Critical physical condition requires immediate intervention
Failure to perform PH or creatinine sampling and lactate levels after angiography
Sepsis and other conditions that cause lactic acidosis
Discontinuation of metformin usage by the patient
Diarrhea, vomiting, and other conditions that predispose the patient to dehydration
Increase serum creatinine by more than 1.5 mg / dL
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization:The card shuffling method will be used.in this method, we prepare an equal number of interventions and controls cards for both groups and after merging the cards, by assigning the number to the samples, for each sample, we remove the card at the same time. If the card is out of the control group, that person is in the control group, and if the intervention card is out, the person is in the group. It will be an intervention
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
Ethics committee of AlborzUniversity of Medical Sciences
Street address
Safarian Alley ,Golshahr,Deputy of Research and Technology
City
Karaj
Province
Alborz
Postal code
3198537646
Approval date
2018-10-13, 1397/07/21
Ethics committee reference number
IR.ABZUMS.REC.1397.180
Health conditions studied
1
Description of health condition studied
Lactic acidosis
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Lactic acidosis
Timepoint
Before the intervention and after coronary angiography up to 48 hours
Method of measurement
blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We continue to prescribe metformin before the angiography and up to 48 hours after the angiography.During these 48 hours, we follow up the patients and measure their plasma lactic acid levels and blood pH.In case of dehydration, we hydrate patients with normal saline serum to prevent lactic acidosis due to dehydration
Category
Other
2
Description
Control group: Up to 48 hours after angiography, we discontinue prescription of metformin and control their lactic acid and blood pH.