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IRCT20130428013159N12 IRCT 2020-06-16 Mashhad University of Medical Sciences Effect of glargine insulin on hyperglycemic control in type II diabetic patients A clinical trial to compare the effectiveness of glargine insulin and regular insulin in hyperglycemic control among type II diabetic patients undergoing on-pump coronary artery bypass graft before, during, and after the operation 2020-08-22 anticipated 80 Complete https://irct.ir/trial/48905 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects will be randomly assigned into two groups of 80 patients with www.sealedenvelope.com website. A noninvolved researcher will determine the random assignment sequencing base on block randomization. This site is designed that random assignment groups with no restriction, Blinding description: Type II diabetic patients who are candidates for on-pump coronary artery bypass graft surgery at the Ghaem Hospital, Mashhad, Iran, are chosen. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection is blind to group allocation and the type of drugs. 3 Condition 1: Type II diabetic. Condition 2: Cardiovascular disease. Intervention 1: Intervention group: The intervention group will receive 0.2 units/kg glargine insulin 2 hours before the surgery. Based on the Van den Berghe national protocol, regular insulin injection unit is equivalent to the blood glucose of patient divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40. Intervention 2: Control group: The control group will receive 0.2 units/kg dextrose 5% 2 hours before the surgery. Based on the Van den Berghe national protocol, regular insulin injection unit is equivalent to the blood glucose of patient divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40. Yes - There is a plan to make this available What will be shared: The total data to be included are the primary and secondary effects to be shared. When: 6 months after printing results To whom: Our data will only be available to researchers working in science center and university. Conditions: Our data will be available for scholars working in science center and university. Where to obtain: Shima Sheybani provides the analysis code to the applicants via email: Sheybanish@mums.ac.ir How to obtain: Applicants can respond to the email of the respondent and receive a response within a week. Comments:
public Shima Sheybani
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0000 Sheybanish@mums.ac.ir Mashhad University of Medical Sciences scientific Shima Sheybani
Ghaem Hospital, Ahmadabad Street, Dr. Ali Shariati Square
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0000 Sheybanish@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age of 35-65 years Sustaining ASA II Blood sugar of 150-350 mg/dl Lack of a simultaneous emergency surgery or heart valve surgery 35 years 65 years Both Having underlying diseases (e.g., pulmonary, liver, kidney, thyroid, and digestive diseases) Having history of open-heart surgery Fever Trauma Carotid artery involvement Sensitivity to insulin glargine E11 I25 Type 2 diabetes mellitus Chronic ischaemic heart disease Treatment - Drugs Treatment - Drugs Intervention group: The intervention group will receive 0.2 units/kg glargine insulin 2 hours before the surgery. Based on the Van den Berghe national protocol, regular insulin injection unit is equivalent to the blood glucose of patient divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40. Control group: The control group will receive 0.2 units/kg dextrose 5% 2 hours before the surgery. Based on the Van den Berghe national protocol, regular insulin injection unit is equivalent to the blood glucose of patient divided by 150. The patients will receive these injections intravenously during and after the surgery. After the surgery, in the ICU, the blood glucose level of patient will be subtracted by 140; accordingly, each patient will receive 4 units of regular subcutaneous insulin injection for every 40. Blood glucose. Timepoint: Before the surgery, every 2 hours intraoperatively, and every 4-24 hours after the surgery. Method of measurement: Glucose meter. Long hospital days in ICU. Timepoint: After intervention. Method of measurement: The questionnaire. Type of antibiotic used. Timepoint: After intervention. Method of measurement: The questionnaire. Wound dehiscence. Timepoint: After intervention. Method of measurement: The questionnaire. Mashhad University of Medical Sciences Approved 2020-02-18 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)