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IRCT20231011059689N1 IRCT 2023-10-16 Esfahan University of Medical Sciences comparison of the effect of the three methods of hemofiltration during CABG on kidney function comparison of the effect of modified and conventional hemofiltration and combination of the two methods during cardiopulmonary bypass during coronary artery bypass graft surgery (CABG) on kidney function 2023-10-13 anticipated 60 Complete https://irct.ir/trial/73113 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: Eligible patients are assigned to three intervention groups using block randomization method. In this way, according to the three groups of intervention and the type of intervention, 120 blocks of 6 that are a combination of interventions will be formed. And then among these blocks, 810 blocks will be randomly selected and based on that, the patients in each block will be assigned to the desired intervention group, Blinding description: This study will be conducted in a double-blind manner, so that the patient and the person analyzing the data will not know about the intervention groups.there will be no possibility of blinding for the doctor and nurse. N/A : Comparing the effect of hemofiltration with modified and conventional methods during heart and lung pumping on kidney function (24-hour urine volume, glomerular filtration rate and CrCl after surgery. Intervention 1: Intervention group: the group in which hemofiltration is performed by the common method (CUF/Conventional). In this group, during heart and lung bypass, the blood is transferred to the hemofilter through the high-pressure part of cardioplegia and passes through the fibers and removes excess fluids and inflammatory factors. Intervention 2: Intervention group: Intervention group: the group in which hemofiltration is performed by a new or advanced method (MUF/modified). In this method, after completing the cardiopulmonary bypass, the blood is transferred to the cardioplegia head pump through the venous line and transferred to the hemofilter through the power of this pump, and after removing excess fluids and inflammatory factors, it is returned to the patient's arterial system through the arterial line. Intervention 3: Intervention group: A group in which both MUF (new) and CUF (common) methods are performed. 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 A decision will be made depending on the opinion of the esteemed statistics expert and the esteemed tutor.
public Dr Mehran Shahzamani
the third moshtaq st. , Salman Farsi st. , Chamran center of cardiovascular surgery , Isfahan , Iran
اصفهان Iran (Islamic Republic of) 8179689367 0098 31 2600961 drshahzamani@yahoo.com Esfahan University of Medical Sciences scientific Dr Mehran Shahzamani
the third moshtaq st. , Salman Farsi st. , Chamran center of cardiovascular surgery , Isfahan , Iran
اصفهان Iran (Islamic Republic of) 8179689367 0098 31 2600961 drshahzamani@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) patients between 35 and 60 years old consciously able to sign a consent letter for participating in this research a candidate for coronary artery bypass graft. recognized by a left ventricle ejection fraction of more than 45% recognized by a gloumeral filtarion rate between 70 and 120 35 years 60 years Both patients recognized by a left ventricle ejection fraction of less than 45% recent MI a gloumeral filtration rate of less than 70 mili litrs per minute kidney failure serum creatinine of more than 1.3 miligrams per decilitr emergency surgery a history of diabetic nephropathy a conjoint valve surgery proteinuria Treatment - Other Treatment - Other Treatment - Other Intervention group: the group in which hemofiltration is performed by the common method (CUF/Conventional). In this group, during heart and lung bypass, the blood is transferred to the hemofilter through the high-pressure part of cardioplegia and passes through the fibers and removes excess fluids and inflammatory factors. Intervention group: Intervention group: the group in which hemofiltration is performed by a new or advanced method (MUF/modified). In this method, after completing the cardiopulmonary bypass, the blood is transferred to the cardioplegia head pump through the venous line and transferred to the hemofilter through the power of this pump, and after removing excess fluids and inflammatory factors, it is returned to the patient's arterial system through the arterial line. Intervention group: A group in which both MUF (new) and CUF (common) methods are performed Serum creatinine. Timepoint: before coronary artery bupass graft surgery - 24 hours after CABG - 72 hours after CABG. Method of measurement: Collection of venous blood sample and measurement of serum creatinine in clinical laboratory. Creatinine clearance. Timepoint: before coronary artery bupass graft surgery - 24 hours after CABG - 72 hours after CABG. Method of measurement: calculating the amount using the quantity of serum creatinine and the formula : CrCl(ml⁄min) = ((140-age)*lean body weight(kg))/(serum creatinine(mg/dl)*72) * (0.85 if female). Gloumeral filtration rate. Timepoint: before coronary artery bupass graft surgery - 24 hours after CABG - 72 hours after CABG. Method of measurement: Calculation of the amount based on the amount of serum creatinine and a defined constant with the help of the Cockcroft-Gallt formula : eGFR=((140-age)*weight*constant)/(serum creatinine) constant = 1.23 for men and 1.04 for women. Esfahan University of Medical Sciences Approved 2023-10-11 Ethics committee of isfahan university of medical science No 412, fifth alley, Mehryar st, Janbazan st Isfahan Isfehan Iran (Islamic Republic of)