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IRCT20180603039966N2 IRCT 2022-11-12 Gorgan University of Medical Sciences ANH effect on hemodynamic and blood transfusion rate in CABG patients Evaluation of the effect of Acute Normovolemic Hemodilution(ANH) on hemodynamics and blood transfusion rate in patients undergoing on-pump CABG 2022-11-21 anticipated 172 Complete https://irct.ir/trial/57740 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Based on the table of random numbers, a column is randomly selected and choose the right side column, If the last digit of the number selected is the same as the patient's last digit case number, the patient will be in the intervention group, and otherwise in the control group, Blinding description: The professor does all the procedures and the data is recorded by the anesthesia technician. The data analyzer does the analysis based on groups A and B. The patient is anesthetized during the entire surgery and procedure and unaware of the study groups. 3 Patients undergoing On-Pump CABG. Intervention 1: Intervention group: Patients who are admitted to Amir-al-Momenin hospital in Kordkoy and Baqiyatallah hospital in Tehran for elective CABG who undergoes Acute Normovolemic Hemodilution. Every 1cc of blood taken from the patient's arterial catheter is compensated with 3cc of intravenous normal saline, the parameters are measured, and the stored blood is injected into the patient at the end of the surgery. Intervention 2: Control group: Intervention group: Patients who are admitted to Amir-al-Momenin hospital in Kordkoy and Baqiyatallah hospital in Tehran for elective CABG who does not undergo Acute Normovolemic Hemodilution. In these patients, an arterial catheter is routinely inserted and hemodynamic parameters are also recorded. 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 further information
public Amirali Jabbari
Shast-kola Road, Hirkan blvd
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 2651 dr.a.jabbari@gmail.com Gorgan University of Medical Sciences scientific Amirali Jabbari
Shast-kola Road, Hirkan blvd
Gorgan Iran (Islamic Republic of) 4934174515 +98 17 3245 2651 dr.a.jabbari@gmail.com Gorgan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) CABG candidates with hemoglubin level above 14 g/dL CABG candidates with left Ventricular Ejection Fraction above 35% no limit no limit Both Patients refusal to participate History of cerebrovascular accident(ischemic or hemorrhagic) History of carotid stenosis History of ischemia or active bleeding(GI bleeding, mesenteric ischemia, claudication) History of renal failure History of liver failure I25.70 Atherosclerosis of coronary artery bypass graft(s), unspecified, with angina pectoris Treatment - Other Treatment - Other Intervention group: Patients who are admitted to Amir-al-Momenin hospital in Kordkoy and Baqiyatallah hospital in Tehran for elective CABG who undergoes Acute Normovolemic Hemodilution. Every 1cc of blood taken from the patient's arterial catheter is compensated with 3cc of intravenous normal saline, the parameters are measured, and the stored blood is injected into the patient at the end of the surgery. Control group: Intervention group: Patients who are admitted to Amir-al-Momenin hospital in Kordkoy and Baqiyatallah hospital in Tehran for elective CABG who does not undergo Acute Normovolemic Hemodilution. In these patients, an arterial catheter is routinely inserted and hemodynamic parameters are also recorded. Need for blood transfusion. Timepoint: Will be recorded during surgery and until the discharge from the ICU. Method of measurement: Number of packed cell transfused. Mean Arterial Pressire(MAP). Timepoint: Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN. Method of measurement: Transducer via Arterial line catheter. Systolic Blood Pressure(SBP). Timepoint: Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN. Method of measurement: Transducer via Arterial line catheter. Diastolic Blood Pressure(DBP). Timepoint: Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN. Method of measurement: Transducer via Arterial line catheter. Urine Output(U/O). Timepoint: Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN. Method of measurement: Urinary drainage Bag. Central Vein Pressure. Timepoint: Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN. Method of measurement: CVP Manometer set. Arterial Blood PH. Timepoint: Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN. Method of measurement: ABG Analyzer. Partial pressure of oxygen(Pao2). Timepoint: Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN. Method of measurement: ABG Analyzer. Partial pressure of carbon dioxide (PaCO2). Timepoint: Will be recorded during surgery and also at 0, 6, 12, 24 hours after the surgery, And if necessary, will be assessed PRN. Method of measurement: ABG Analyzer. Gorgan University of Medical Sciences Approved 2021-10-31 Glestan Medical University Ethics Committee shastkola road Gorgan Golestan Iran (Islamic Republic of)