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IRCT20120215009014N202 IRCT 2017-12-31 Hamedan University of Medical Sciences Evaluation of the protective effect of N-Acetyle-Cysteine versus placebo on the heart of diabetic patients undergoing CABG Evaluation of the protective effect of N-Acetyle-Cysteine versus placebo on the heart of diabetic patients undergoing CABG: a triple blind randomized clinical trial 2017-05-05 anticipated 240 Complete https://irct.ir/trial/28335 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to the intervention and control groups through drawing of lots, Blinding description: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind. 2 Coronary artery bypass graft. Intervention 1: Intervention group: Intravenous injection of N-Acetyle-Cysteine 3 mg/kg single dose one hour before surgery. Intervention 2: Control group: Intravenous injection of normal saline 3 ml/kg single dose one hour before surgery. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of study as well as approval of the financial supporting organization.
public Dr Zahra Mohammadzadeh Vijeh
Farshchian Heart Hospital, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 1740 mohammadzade84@gmail.com Hamedan University of Medical Sciences scientific Dr Ahmad Reza Salim Bahrami
Farshchian Heart Hospital, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 1740 salimbahramidr@yahoo.com Hamedan University of Medical Sciences Iran (Islamic Republic of) Age of 45 to 75 years Male gender Diabetic Candidate for undergoing CABG Cardiac index at least 2.5 L/m2 45 years 75 years Male Myocardial infarction after CABG Moderate to severe Valvular disorder Taking inotropic medication for a long time before or after surgery Arm circumference larger than barometric cuff I25.70 Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris Treatment - Drugs Placebo Intervention group: Intravenous injection of N-Acetyle-Cysteine 3 mg/kg single dose one hour before surgery. Control group: Intravenous injection of normal saline 3 ml/kg single dose one hour before surgery. Assessing cardiac ejection fraction. Timepoint: before and 3 days after surgery. Method of measurement: using transthoracic echocardiography. Assessing cardiac index. Timepoint: before and 3 days after surgery. Method of measurement: using transthoracic echocardiography. Hamedan University of Medical Sciences Approved 2017-04-22 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)