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IRCT20230508058118N1 IRCT 2023-11-05 Esfahan University of Medical Sciences Investigating the effect of acute normovolemic blood dilution on the function of vital organs in patients who are candidates for heart surgery Investigating the effect of acute normovolemic blood dilution on the function of vital organs in patients who are candidates for heart surgery 2023-11-05 anticipated 60 Complete https://irct.ir/trial/71666 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: This stage will be by randomized block design method. At this stage, patients will be divided into 2 blocks (30 blocks of 2). Then they are sorted according to the national code (the larger national code of the first row of the block and the smaller national code of the second row of the block). After that, we refer to the table of random numbers for each block. If the selected number was from 0 to 4, the patient in the first row will join group A and the patient in the second row will join group B. If the selected number is from 5 to 9, the patient in the first row will join group B and the patient in the second row will join group A. After 30 patients of group A and 30 patients of group B were determined, group A will be the intervention group and group B will be the control group, Blinding description: The patient, all study investigators and data analyzers were blinded to patient grouping. The patient is unconscious during the intervention, and the study researchers (data collectors) and data analyzers are unaware of the intervention. N/A Coronary artery bypass surgery. Intervention 1: Intervention group: Storing the blood of patients before the operation and injecting it after the operation. Intervention 2: Control group: Routine open heart surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is Information is kept confidential.
public Amirreza Mozhganian
Alzahra Hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 amirreza75mojganian@gmail.com Esfahan University of Medical Sciences scientific Amirreza Mozhganian
Alzahra Hospital, Sofeh Blvd.
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 amirreza75mojganian@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Adult patients candidates for heart surgery Ejection fraction more than 40% Hemoglobin greater than and equal to 14 No kidney, liver, respiratory or brain failure no limit no limit Both Pump time more than 120 minutes Use of circulatory arrest Reoperation due to surgical bleeding I97.190 Other postprocedural cardiac functional disturbances following cardiac surgery Rehabilitation N/A Intervention group: Storing the blood of patients before the operation and injecting it after the operation Control group: Routine open heart surgery Postoperative renal function. Timepoint: 24 and 48 hours after the operation. Method of measurement: Creatinine and blood urea nitrogen test. Postoperative pulmonary function. Timepoint: 24 and 48 hours after the operation. Method of measurement: Venous blood gas test. Esfahan University of Medical Sciences Approved 2022-11-10 Ethics committee of Isfahan University of Medical Sciences Vice Chancellor for Research and Technology, Hezar Jerib St.sfahan University of MedicalSciences and Health Services, Building No. 4 Isfahan Isfehan Iran (Islamic Republic of)