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IRCT201108147325N1 IRCT 2011-09-17 Vice Chancellor, Tabriz University of Medical Sciences Effect of citrate-phosphate-Dextrose Solution on reperfusion Injury in Coronary Artery Bypass Surgical Patient Undergoing Cardiopulmonary Bypass Clinical trial of citrate-phosphate-Dextrose Solution on reperfusion Injury in Coronary Artery Bypass 2011-02-20 anticipated 50 Complete https://irct.ir/trial/7768 interventional Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: After selecting the group of patients from on pump and off pump; according to the considerations on the status of involved vessels anatomic; with renal disease; cerebrovascular disease; a history of stroke; severe ascending aorta atherosclerosis relatively severe carotid artery stenosis; study continued. 2-3 cardiac. Intervention 1: The control group was injected only pure blood. But all routine procedures were performed for them. Blood samples (10 cc for each time ) were measured respectively for measurement of cardiac enzymes and inflammatory factors in before opening the bypass, before clamping and 10 minutes after opening the clamping of the coronary sinus and venous blood, and also when patients arrival in ICU and the first and second morning after surgery was taken only from vein. Intervention 2: Before the surgery all of the patients in both groups were inform about the benefits of this research and then, if they signed the consent form, will entrance to the study. Patients were assured that, they can come out of research any time. The patients were anesthetized during surgery and were not aware of citrate phosphate dextrose solution injection or infusion at the end of the pump. The surgeon and cardiologist who measured of ejection fraction before and after the operation and administration of the laboratory were not informed about the injection or not injection of citrate phosphate dextrose solution during surgery. In case group after surgery and before the opening of the aortic clamping, warm blood shot of citrate phosphate dextrose solution (3cc to 100 cc) amount of (100 cc/min/m2BSA) was injected for three minutes, until perfusion pressure maintaining of 30 mmHg. After the ending of warm blood shot injection, calculating the net blood pressure amount 50 to75 mmHg until the heart rate (7 to 10 minutes) continued. In control group only injected pure blood. Blood samples (10 cc for each time) were measured respectively for measurement of cardiac enzymes and inflammatory factors in before opening the bypass, before clamping and 10 minutes after opening the clamping of the coronary sinus and venous blood, and also when patient's arrival in ICU and the first and second morning after surgery was taken only from vein.
public Dr Alireza Yaghoubi
Golgasht Street, Chancellor Department, Madani Heart Center, Tabriz University of Medical Sciences, Iran_ Tabriz.
Tabriz Iran (Islamic Republic of) +98 41 1335 7770 Yaghoubi@tbzmed.ac.ir; alireza_yaghoubi@yahoo.com Tabriz University of Medical Sciences scientific Dr Alireza Yaghoubi
Golgasht Street, Chancellor Department, Madani Heart Center, Tabriz University of Medical Sciences, Iran_ Tabriz.
Tabriz Iran (Islamic Republic of) +98 41 1335 7770 Yaghoubi@tbzmed.ac.ir; alireza_yaghoubi@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria were; not having another heart attack or another heart surgery at same time; no previous heart surgery; positive history of past severe disease; on-emergency surgery; the absence of high risk surgery; to abandon cases involving one vessel; uncontrolled diabetes; lack of severe left ventricular dysfunction; no MI with Q wave in 6 past weeks; lack of severe lesions of LM (greater than equal to 50%); unstable angina; non-cytotoxic drugs and radiation use; no recent blood transfusion in past month and willingness to participate in the study; Exiting criteria were; the operation of the on pump switch to off pump; addition of other surgery such as surgery aneurysmectomy LV; performed endarterctomy on the involved vessels ;prolonged clamping more than 100 minutes; prolonged pump more than 130 minutes; hemolysis of samples obtained from patients; clotting of samples taken from patients; lack of proper storage and transport of samples at the usual time; less than 5 / 1 cc of blood serum sample size.. no limit no limit Both T82.7 Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts Treatment - Drugs Treatment - Drugs The control group was injected only pure blood. But all routine procedures were performed for them. Blood samples (10 cc for each time ) were measured respectively for measurement of cardiac enzymes and inflammatory factors in before opening the bypass, before clamping and 10 minutes after opening the clamping of the coronary sinus and venous blood, and also when patients arrival in ICU and the first and second morning after surgery was taken only from vein. Before the surgery all of the patients in both groups were inform about the benefits of this research and then, if they signed the consent form, will entrance to the study. Patients were assured that, they can come out of research any time. The patients were anesthetized during surgery and were not aware of citrate phosphate dextrose solution injection or infusion at the end of the pump. The surgeon and cardiologist who measured of ejection fraction before and after the operation and administration of the laboratory were not informed about the injection or not injection of citrate phosphate dextrose solution during surgery. In case group after surgery and before the opening of the aortic clamping, warm blood shot of citrate phosphate dextrose solution (3cc to 100 cc) amount of (100 cc/min/m2BSA) was injected for three minutes, until perfusion pressure maintaining of 30 mmHg. After the ending of warm blood shot injection, calculating the net blood pressure amount 50 to75 mmHg until the heart rate (7 to 10 minutes) continued. In control group only injected pure blood. Blood samples (10 cc for each time) were measured respectively for measurement of cardiac enzymes and inflammatory factors in before opening the bypass, before clamping and 10 minutes after opening the clamping of the coronary sinus and venous blood, and also when patient's arrival in ICU and the first and second morning after surgery was taken only from vein. Measurement of cardiac enzymes and inflammatory factors. Timepoint: Oxidative stress markers in 5 stage and cardiac enzymes in 3 stage of surgery measured. Method of measurement: 10 cc of blood was taken in , before the bypass ,before opening the clamping, opening 10 minutes after clamping from the coronary sinus , first day and second day after surgery from venous blood . Total serum antioxidant. Timepoint: Before ischemia and after reperfusion. Method of measurement: Total antioxidant capacity in serum using a commercial kit Ltd Randox Laboratories UK, CatNo.NX2332 were measured. Vice Chancellor, Tabriz University of Medical Sciences Approved 2010-12-06 Ethics Committee of Tabriz University of Medical Sciences Golgasht Street, Tabriz University of Medical Sciences, Vice Chancellor, Tabriz _Iran. Tabriz Iran (Islamic Republic of)