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IRCT20220716055477N1 IRCT 2022-08-15 Rajaee Heart Center Evaluating the effect of Del Nido cardioplegia solution containing Vitamin C on perioperative clinical outcomes and laboratory criteria of CABG patients Evaluating the effect of Del Nido cardioplegia solution containing Vitamin C on perioperative clinical outcomes and laboratory criteria of CABG patients 2022-09-06 anticipated 70 Complete https://irct.ir/trial/64773 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization with size 6 and Individual randomization unit (using https://www.sealedenvelope.com/simple-randomiser/v1/lists;CREATE A RANDOMISATION LIST) a list with 72 numbers that accidentally divided into two different groups was made. First group consider as intervention group and second group consider as control groups. For gathering data in this trial consent form will be taken from suitable candidates before entering the operation room and then patients in order of acceptance in OR (with completely interchangeable orders) based on created numbers that described earlier will be divided into vitamin C group (35 patients) and control group (35 patients) and eventually 70 patients will participate in this trial. N/A Coronary Artery Bypass Graft Surgery. Intervention 1: Intervention group: adding 3 gram of injectable Vitamin C ( 6 VITAMIN C DP 500MG/5ML AMP) to Del Nido cardioplegia solution (1 L Plasma-Lyte A base solution to which the following are added: Mannitol 20%, 16.3 mL Magnesium sulfate 50%, 4 mL Sodium bicarbonate 8.4%, 13 mL Potassium chloride (2 mEq/mL), 13 mL Lidocaine 1%, 13 mL). Intervention 2: Control group: Inject Del Nido cardioplegia solution (1 L Plasma-Lyte A base solution to which the following are added: Mannitol 20%, 16.3 mL Magnesium sulfate 50%, 4 mL Sodium bicarbonate 8.4%, 13 mL Potassium chloride (2 mEq/mL), 13 mL Lidocaine 1%, 13 mL). Yes - There is a plan to make this available What will be shared: Evaluating the effect of Del Nido cardioplegia solution containing Vitamin C on perioperative clinical outcomes and laboratory criteria of CABG patients When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Science production and teaching methodology Where to obtain: Dr. Farshad Jalili Shahandashti Jalilishfarshad@gmail.com How to obtain: Valid request via academic email Comments:
public Mohammadhadi Mozayan
NO. 4, left hand , 8th South Parsian Blvd, Rokabad Town, Shiraz
Shiraz Iran (Islamic Republic of) 7149635572 +98 71 3242 4118 hadimozayan@gmail.com Rajaee Heart Center scientific Mohammadhadi Mozayan
NO. 4, left hand , 8th South Parsian Blvd, Rokabad
Shiraz Iran (Islamic Republic of) 7149635572 +98 71 3242 4118 hadimozayan@gmail.com Rajaee Heart Center Iran (Islamic Republic of) Tendency to participate Consent Age between 30 to 70 LVEF more than 30% 30 years 70 years Both Above normal range cardiac enzymes History of sternotomy and previous cardiac surgeries History of Liver, Kidney, Pulmonary diseases Valve problems that requires concurrent surgery Having pacemaker Pregnancy History of allergic reaction to Vitamin C G6PD deficiency I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Drugs Treatment - Drugs Intervention group: adding 3 gram of injectable Vitamin C ( 6 VITAMIN C DP 500MG/5ML AMP) to Del Nido cardioplegia solution (1 L Plasma-Lyte A base solution to which the following are added: Mannitol 20%, 16.3 mL Magnesium sulfate 50%, 4 mL Sodium bicarbonate 8.4%, 13 mL Potassium chloride (2 mEq/mL), 13 mL Lidocaine 1%, 13 mL) Control group: Inject Del Nido cardioplegia solution (1 L Plasma-Lyte A base solution to which the following are added: Mannitol 20%, 16.3 mL Magnesium sulfate 50%, 4 mL Sodium bicarbonate 8.4%, 13 mL Potassium chloride (2 mEq/mL), 13 mL Lidocaine 1%, 13 mL) Troponin I is a cardiac and skeletal muscle protein family. It is a part of the troponin protein complex, where it binds to actin in thin myofilaments to hold the actin-tropomyosin complex in place. Troponin I prevents myosin from binding to actin in relaxed muscle. When calcium binds to the troponin C, it causes conformational changes which lead to dislocation of troponin I. Afterwards, tropomyosin leaves the binding site for myosin on actin leading to contraction of muscle. The letter I is given due to its inhibitory character. It is a useful marker in the laboratory diagnosis of heart attack. It occurs in different plasma concentration but the same circumstances as troponin T - either test can be performed for confirmation of cardiac muscle damage and laboratories usually offer one test or the other. Timepoint: pre-operation, upon admission to the Intensive Care Unit, and 24 hours later. Method of measurement: Using accurate laboratory kits. Creatine kinase-MB (CK-MB) is a form of an enzyme found primarily in heart muscle cells. This test measures CK-MB in the blood.CK-MB is one of three forms (isoenzymes) of the enzyme creatine kinase (CK). These isoenzymes include :CK-MM (found in skeletal muscles and the heart)CK-MB (found mostly in the heart, but small amounts found in skeletal muscles)CK-BB (found mostly in the brain and smooth muscle, such as the intestines and uterus)CK is released from muscle cells and is detectable in the blood whenever there is muscle damage. The small amount of CK that is normally in the blood is primarily CK-MM. CK-BB almost never gets into the blood, and CK-MB will typically only be present in significant amounts when the heart is damaged. A CK test measures the total level but does not distinguish between the three isoenzymes. When there is an increased amount of CK present in the blood, the CK-MB test can be used to determine whether it is due to heart damage or is more likely to be related to skeletal muscle injury. Timepoint: pre-operation, upon admission to the Intensive Care Unit, and 24 hours later. Method of measurement: Using accurate laboratory kits. Blood urea nitrogen (BUN) is a medical test that measures the amount of urea nitrogen found in blood. The liver produces urea in the urea cycle as a waste product of the digestion of protein. Normal human adult blood should contain 6 to 20 mg/dL (2.1 to 7.1 mmol/L) of urea nitrogen. Individual laboratories will have different reference ranges as the assay used can vary between laboratories. The test is used to detect renal problems. Timepoint: pre-operation, upon admission to the Intensive Care Unit, 24 and 48 hours later. Method of measurement: Using accurate laboratory kits. Serum creatinine (a blood measurement) is an important indicator of kidney health because it is an easily measured byproduct of muscle metabolism that is excreted unchanged by the kidneys. Creatinine itself is produced via a biological system involving creatine, phosphocreatine (also known as creatine phosphate), and adenosine triphosphate (ATP, the body's immediate energy supply). Timepoint: pre-operation, upon admission to the Intensive Care Unit, 24 and 48 hours later. Method of measurement: Using accurate laboratory kits. Liver function tests (LFTs or LFs), also referred to as a hepatic panel, are groups of blood tests that provide information about the state of a patient's liver. The liver transaminases aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) are useful biomarkers of liver injury in a patient with some degree of intact liver function. Timepoint: pre-operation, upon admission to the Intensive Care Unit, 24 and 48 hours later. Method of measurement: Using accurate laboratory kits. Rajaee Heart Center Approved 2022-07-16 Ethics committee of Rajaee Heart Center Rajaee Heart Center, Next to Mellat Park, Valiasr street Tehran Tehran Iran (Islamic Republic of)