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IRCT20170620034666N2 IRCT 2019-09-24 Isfahan University of Medical Sciences Comparison of the effect of methylprednisolone and dexamethasone in prime solution Comparative study of clinical outcomes of methylprednisolone and dexamethasone in prime solution during cardiopulmonary pump after coronary artery bypass grafting in patients candidate for bypass surgery 2019-07-31 anticipated 62 Complete https://irct.ir/trial/41614 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random number table and block randomization method will be used using http://www.randomizer.org.In this method, eligible patients are divided into blocks of 4 patients. We create random numbers using computer.Based on the determined numerical range to enter individuals in each group, half of the patients in each block will receive methylprednisolone and half of them receive dexamethasone, Blinding description: Participants in this study will be unaware of the type of drug being administered and analyzer will analyze the data as a code. 3 Coronary artery bypass graft surgery. Intervention 1: Intervention group 1: In dexamethasone group, 8 mg dexamethasone (Iran Hormone Company) is used in the prime solution. In the first 24 hours after surgery, the patient receives 8 mg dexamethasone every 8 hours and in the second 24 hours after surgery every 8 hours 4 mg dexamethasone and it is discontinued after the third 24 hours. Intervention 2: Intervention group 2: In methylprednisolone group, 8 mg methylprednisolone (Iran Hormone Company) is used in the prime solution. In the first 24 hours after surgery, the patient receives 8 mg methylprednisolone every 8 hours and in the second 24 hours after surgery every 8 hours 4 mg methylprednisolone and it is discontinued after the third 24 hours. Yes - There is a plan to make this available What will be shared: After finishing the study the data will be available When: After publishing the article To whom: Faculty menbers Conditions: Contacting the scientist responsible by email causes the data to be used in order to use the data in scientific research such as meta-analysis or secondary analysis. Where to obtain: Scientific responsible can provide the study data to academic researchers without the name of individuals How to obtain: Just forwarding email to scientific responsible of this trial is enough Comments:
public Mehran Shahzamani
Chamran hospital, Salman Farsi Blv, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3670 1227 m.shahzamani@med.mui.ac.ir Esfahan University of Medical Sciences scientific Mehran Shahzamani
Chamran hospital, Salman Farsi Blv, Isfahan
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3670 1227 m.shahzamani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All patients undergoing coronary artery bypass grafting surgery Consent to participate in the study 40 years 60 years Both History of valve surgery Less than 40 years old and over than 60 years old Ejection fraction less than 40% T82.2 Mechanical complication of coronary artery bypass graft and biological heart valve graft Treatment - Drugs Treatment - Drugs Intervention group 1: In dexamethasone group, 8 mg dexamethasone (Iran Hormone Company) is used in the prime solution. In the first 24 hours after surgery, the patient receives 8 mg dexamethasone every 8 hours and in the second 24 hours after surgery every 8 hours 4 mg dexamethasone and it is discontinued after the third 24 hours. Intervention group 2: In methylprednisolone group, 8 mg methylprednisolone (Iran Hormone Company) is used in the prime solution. In the first 24 hours after surgery, the patient receives 8 mg methylprednisolone every 8 hours and in the second 24 hours after surgery every 8 hours 4 mg methylprednisolone and it is discontinued after the third 24 hours. Bleeding. Timepoint: After surgery. Method of measurement: Observation. Hospitalization days. Timepoint: At the time of discharge. Method of measurement: Based on the day. Inotrope intake. Timepoint: After the surgery. Method of measurement: Based on the recorded checklist. Duration of mechanical ventialtion. Timepoint: At the time of discharge. Method of measurement: Based on the hour. Arrhythmia. Timepoint: Continuously until discharge from cardiac intensive care unit. Method of measurement: Electrocardiogram. Isfahan University of Medical Sciences Approved 2019-07-27 Ethics committee of Isfahan University of Medical Sciences Chamran hospital, Salman Farsi Blv, Isfahan Isfahan Isfehan Iran (Islamic Republic of)