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IRCT201202048860N1 IRCT 2013-07-16 Rajaie cardiovascular medical and research center The evaluation and comparison of Coronary sinus Inflammatory and ischemic biomarkers level in retrograde-anterograde versus anterograde cardioplegia during cardiopulmonary bypass surgery: A single blinded randomized controlled trial The evaluation and comparison of Coronary sinus Inflammatory and ischemic biomarkers level in retrograde-anterograde versus anterograde cardioplegia during cardiopulmonary bypass surgery: A single blinded randomized controlled trial 2014-02-20 anticipated 100 Complete https://irct.ir/trial/9329 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Myocardial Infarction. Intervention 1: Control group: cold, Bloody cardioplegic solution (st. Thomas II based) is applied at an initial volume of 1000 mL in all patients. A second or third shot of 300 to 500 mL is given to patients with restarting electrical heart activity or after 20 minutes of cross-clamp time after the previous application. Intervention 2: Intervention group: the initial dose delivered in the same route and the next cardiolpegia will be infused via retrograde catheter 200-300 ml after every distal anastomosis for CABG cases or 300-500 ml every 20 min in other procedures. Antegrade cardioplegia will be re-infused after 40 min for long-time cross clamping time.
public Dr. Alireza Alizadeh Ghavidel
Valiasr Ave, Nyayesh Blvd
Tehran Iran (Islamic Republic of) +98 21 2392 2147 aghavidel@rhc.ac.ir Rajaie heart center scientific Dr. Alireza Alizadeh Ghavidel
Valiasr Ave, Nyayesh Blvd.
Tehran Iran (Islamic Republic of) +98 21 2392 2147 aghavidel@rhc.ac.ir Rajaie Heart Center Iran (Islamic Republic of) Inclusion criteria: all patients undergoing cardiopulmonary bypass surgery at one operator service in our institution were prospectively screened for inclusion in the investigation. Consecutive patients with the following characteristics were selected for inclusion in the study: valvular with at least two vessels coronary disease. Exclusion criteria: total respiratory disability; renal failure (Cr > 2); age ≥ 80 years old; history of MI in 4 weeks preoperatively; failure to retrograde catheter insertion; where total respiratory disability is any of: height-corrected FEV1 (1.1-1.4) and DLCO less than 30 percent predicted (Technical revisions to medical criteria for determinations of disability). 18 years 80 years Both 121 myocardial infarction specified as acute or with a stated duration of 4 weeks (28 days) or less from onset Treatment - Surgery Treatment - Surgery Control group: cold, Bloody cardioplegic solution (st. Thomas II based) is applied at an initial volume of 1000 mL in all patients. A second or third shot of 300 to 500 mL is given to patients with restarting electrical heart activity or after 20 minutes of cross-clamp time after the previous application Intervention group: the initial dose delivered in the same route and the next cardiolpegia will be infused via retrograde catheter 200-300 ml after every distal anastomosis for CABG cases or 300-500 ml every 20 min in other procedures. Antegrade cardioplegia will be re-infused after 40 min for long-time cross clamping time Mortality. Timepoint: 30-day after surgery. Method of measurement: ID. Blood level of IL18 in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes, and 12 hours after completion of CPB. Method of measurement: Laboratory kit. Blood level of Na in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit. Blood level of K in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit. Blood level of Ca in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit. Blood level of Lactate in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit. Blood level of Lactate/Pyruvate in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit. Blood level of HSCRP in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit. Blood level of HCO3 in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit. Blood level of PH in peripheral blood sample. Timepoint: before institution of CPB, on removal of aortic cross-clamp, 30 minutes after completion of CPB. Method of measurement: Laboratory kit. Rajaie cardiovascular medical and research center Approved 2013-06-22 Tehran University of Medical Sciences Junction of Shahid Hemmat and Shahid Chamran expressways Tehran Iran (Islamic Republic of)