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IRCT20210825052284N1 IRCT 2022-09-28 Shahid Beheshti University of Medical Sciences Comparisson of the Efficacy of Ringer's Lactate Serum as a Base Solution in Modified Del Nido Cardioplegia with Standard Del Nido Cardioplegia on the Outcomes in Patients Undergoing Coronary Artery Bypass Graft Comparisson of the Efficacy of Ringer's Lactate Serum as a Base Solution in Modified Del Nido Cardioplegia with Standard Del Nido Cardioplegia on Myocardial Damage Markers and Clinical Outcomes in Patients Undergoing Coronary Artery Bypass Graft 2022-10-23 anticipated 60 Complete https://irct.ir/trial/65917 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method is a simple randomization that is done in the form of individual random units. The tool used to do this is a random numbers table. The method of constructing a random sequence is that first the researcher selects one of the numbers with his eyes closed and then moves in the right direction. Odd numbers are considered for intervention and even numbers are for control. Random concealment is also performed using sequentially numbered sealed opaque envelopes (SNOSE), Blinding description: In this single-blinded study, patients who are candidates for coronary artery bypass grafting are blind to the group assignment. Others, including treating physician, methodologist, statistics specialist, nurses, authors of manuscript, and study designers, will be aware of the classification of patients into the two groups. N/A Coronary artery bypass graft. Intervention 1: Intervention group A: In this study, Ringer's lactate solution is used to cardioplegia in group A (modified Del Nino). Intervention 2: Intervention group B: In this study, plasmalit A solution is used to cardioplegia in group B (Del Nino standard). 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 There is no more information.
public Salimeh Janghorban
No. 2, Derakhti Ave., Hosseininejad Ave., Salman Farsi Ave., Namjoo St., Tehran
Tehran Iran (Islamic Republic of) 1615614361 +98 21 7757 9045 Sali.cardiology@yahoo.com Shahid Beheshti University of Medical Sciences scientific Salimeh Janghorban
No. 2, Derakhti Ave., Hosseininejad Ave., Salman Farsi Ave., Namjoo St., Tehran
Tehran Iran (Islamic Republic of) 1615614361 +98 21 1157 9045 Sali.cardiology@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Candidate patients for coronary artery bypass graft Candidate patients for 3 to 4 vascular grafts Age between 18 and 75 years Written informed consent to participate in the study An ejection fraction higher than 35% before surgery Lack of multi-organ failure before surgery 18 years 75 years Both Re-operation Proven infection or inflammation within the last month T82.2 Mechanical complication of coronary artery bypass graft and biological heart valve graft Treatment - Drugs Treatment - Drugs Intervention group A: In this study, Ringer's lactate solution is used to cardioplegia in group A (modified Del Nino). Intervention group B: In this study, plasmalit A solution is used to cardioplegia in group B (Del Nino standard). Ejection fraction. Timepoint: Before surgery, after surgery, and 24 hours after admission to the intensive care unit. Method of measurement: Echocardiography. Duration of mechanical ventilation. Timepoint: Daily after surgery. Method of measurement: Medical record of the patients. Arrhythmia incidence. Timepoint: Daily after surgery. Method of measurement: Electrocardiogram device and cardiologist's interpretation. Inotrope administration. Timepoint: Daily after surgery. Method of measurement: Medical record of the patients. Troponin level. Timepoint: Before surgery, after surgery, and 24 hours after admission to the intensive care unit. Method of measurement: Laboratory report. Lactate dehydrogenase level. Timepoint: Before surgery, after surgery, and 24 hours after admission to the intensive care unit. Method of measurement: Laboratory report. Shahid Beheshti University of Medical Sciences Approved 2022-04-12 Research Ethics Committees of School of Medicine, Shahid Beheshti University of Medical Sciences School of medicine of Shahid Beheshti University of medical sciences, Koodakyar Ave., Daneshjoo Blvd,. Yaman St,. Chamran highway. Tehran Tehran Iran (Islamic Republic of)