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IRCT20230218057444N1 IRCT 2023-03-06 Ghoum University of Medical Sciences Evaluating the prescription of short-term and medium-term effects of coenzyme Q۱۰ on the inflammatory system and renal function in patients undergoing open heart surgery Evaluating the prescription of short-term and medium-term effects of coenzyme Q۱۰ on the inflammatory system and renal function in patients undergoing open heart surgery 2023-03-25 anticipated 41 Complete https://irct.ir/trial/68670 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: For randomization, an online random number table is used. Odd numbers are included in the control group and even numbers are included in the experimental group, Blinding description: In this study, after explaining to the patient and obtaining informed consent to participate in the research study, and the use of the drug and its effects, the patient has no knowledge of the type of drug. People in the control group were also given a placebo so that they did not know the type of drug. In order to prevent errors, the outcome evaluator will be unaware of the type of drug injection and the allocation of people in groups. 3 Evaluating the prescription of short-term and medium-term effects of coenzyme Q10 on the inflammatory system and renal function in patients undergoing openheart surgery. Intervention 1: Intervention group: Patients will be divided into two control and intervention groups based on random sampling (permutation blocks). Patients in the intervention group will receive CoQ10 tablets, 300 mg, twice a day every 12 hours, in the period of two days before the operation until the time of discharge from the ICU department and sending to the POST ICU department. Patients in the control group will receive the placebo in the same way, that is, from two days before the operation until the time of discharge from the ICU. Anesthesia induction will be done for all patients with sufentanil 2 µg/kg, nesdonal 3 mg/kg and pancuronium 0.1 mg/kg, and anesthesia will be maintained with 0.5-1% isoflurane and during cardiopulmonary bypass with Pancranium 0.1 mg/kg/h, fentanyl 1-2 µg/kg, and midazolam 0.5-1-1 kg/mg are maintained, and all patients will receive heparin 300 u/kg before cardiopulmonary bypass; until the active coagulation time (ACT) is higher than 480 seconds. . Crystalloid (2000 cc Ringer) and colloid (50 cc albumin) are used to prime the oxygenator in both groups. During CPB, additional heparin will be prescribed to reach the target ACT. After completing CPB and disconnecting from the heparin pump, it is neutralized with protamine sulfate 1 mg per 100 units of heparin; to reach the ACT target of 80-120. In order to measure and evaluate inflammatory factors, 2 ml of arterial blood samples are taken in three time periods at the beginning of the operation, after cardio-pulmonary bypass and 24 hours after entering the ICU. Then, the sample is immediately sent to the relevant laboratories to measure interleukin-10 and interleukin-6 factors, and serology tests are measured by the ELISA kit of MabTag GmbH - Germany.In order to evaluate the performance of all three parameters, creatinine level, blood urea nitrogen and glomerular filtration rate (GFR) are checked. In this way, 2 ml of venous blood samples are sent to the relevant laboratory in three time periods before the operation, after entering the ICU and 4 days later, to measure the amount of creatinine, blood urea nitrogen of the kidney. The concentration of blood urea nitrogen and serum creatinine will be determined using an automatic biochemical analyzer (Hitachi 7600, Japan) in the clinical laboratory. The initial GFR of the patient is calculated before taking the Q10 drug, after entering the ICU and 4 days later. Intervention 2: Control group: Patients will be divided into two control and intervention groups based on random sampling (permutation blocks). Patients in the intervention group will receive CoQ10 tablets, 300 mg, twice a day every 12 hours, in the period of two days before the operation until the time of discharge from the ICU department and sending to the POST ICU department. Patients in the control group will receive the placebo in the same way, that is, from two days before the operation until the time of discharge from the ICU. Anesthesia induction will be done for all patients with sufentanil 2 µg/kg, nesdonal 3 mg/kg and pancuronium 0.1 mg/kg, and anesthesia will be maintained with 0.5-1% isoflurane and during cardiopulmonary bypass with Pancranium 0.1 mg/kg/h, fentanyl 1-2 µg/kg, and midazolam 0.5-1-1 kg/mg are maintained, and all patients will receive heparin 300 u/kg before cardiopulmonary bypass; until the active coagulation time (ACT) is higher than 480 seconds. . Crystalloid (2000 cc Ringer) and colloid (50 cc albumin) are used to prime the oxygenator in both groups. During CPB, additional heparin will be prescribed to reach the target ACT. After completing CPB and disconnecting from the heparin pump, it is neutralized with protamine sulfate 1 mg per 100 units of heparin; to reach the ACT target of 80-120. In order to measure and evaluate inflammatory factors, 2 ml of arterial blood samples are taken in three time periods at the beginning of the operation, after cardio-pulmonary bypass and 24 hours after entering the ICU. Then, the sample is immediately sent to the relevant laboratories to measure interleukin-10 and interleukin-6 factors, and serology tests are measured by the ELISA kit of MabTag GmbH - Germany.In order to evaluate the performance of all three parameters, creatinine level, blood urea nitrogen and glomerular filtration rate (GFR) are checked. In this way, 2 ml of venous blood samples are sent to the relevant laboratory in three time periods before the operation, after entering the ICU and 4 days later, to measure the amount of creatinine, blood urea nitrogen of the kidney. The concentration of blood urea nitrogen and serum creatinine will be determined using an automatic biochemical analyzer (Hitachi 7600, Japan) in the clinical laboratory. The initial GFR of the patient is calculated before taking the Q10 drug, after entering the ICU and 4 days later. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be accessed for each patient When: Access to the data will be free forever after the article is published To whom: Academic institutions and researchers in the relevant research field Conditions: The data will be used by mentioning the names of the researchers doing the project Where to obtain: They can communicate with the responsible author of the article and project manager through email How to obtain: After receiving the e-mail by the researchers, the information will be provided to the requester within a week Comments:
public Motahareh Ghodrati
Shahid Beheshti blv, Shahid Beheshti Hospital
Qom Iran (Islamic Republic of) 3716987366 +98 25 3664 1601 m.ghodrati87@gmail.com Ghoum University of Medical Sciences scientific Motahareh Ghodrati
Shahid Beheshti blv, Shahid Beheshti Hospital
Qom Iran (Islamic Republic of) 3716987366 +98 25 3664 1601 m.ghodrati87@gmail.com Ghoum University of Medical Sciences Iran (Islamic Republic of) The inclusion criteria for all patients over 18 years of age, suffering from coronary artery disease undergoing CABG surgery, is the glomerular filtration rate (GFR) greater than 45ml/min. 18 years no limit Both current coenzyme Q10 therapy, which has high-risk features that warrant urgent coronary angiography (within 4 hours); the existence of sensitivity to CoQ10, people with kidney failure who need dialysis; Exposure to contrast media in the past 7 days, left ventricular ejection fraction (LVEF) <30, administration of N-acetylcysteine within 48 hours postoperatively, and refusal of consent. Prevention Prevention Intervention group: Patients will be divided into two control and intervention groups based on random sampling (permutation blocks). Patients in the intervention group will receive CoQ10 tablets, 300 mg, twice a day every 12 hours, in the period of two days before the operation until the time of discharge from the ICU department and sending to the POST ICU department. Patients in the control group will receive the placebo in the same way, that is, from two days before the operation until the time of discharge from the ICU. Anesthesia induction will be done for all patients with sufentanil 2 µg/kg, nesdonal 3 mg/kg and pancuronium 0.1 mg/kg, and anesthesia will be maintained with 0.5-1% isoflurane and during cardiopulmonary bypass with Pancranium 0.1 mg/kg/h, fentanyl 1-2 µg/kg, and midazolam 0.5-1-1 kg/mg are maintained, and all patients will receive heparin 300 u/kg before cardiopulmonary bypass; until the active coagulation time (ACT) is higher than 480 seconds. . Crystalloid (2000 cc Ringer) and colloid (50 cc albumin) are used to prime the oxygenator in both groups. During CPB, additional heparin will be prescribed to reach the target ACT. After completing CPB and disconnecting from the heparin pump, it is neutralized with protamine sulfate 1 mg per 100 units of heparin; to reach the ACT target of 80-120. In order to measure and evaluate inflammatory factors, 2 ml of arterial blood samples are taken in three time periods at the beginning of the operation, after cardio-pulmonary bypass and 24 hours after entering the ICU. Then, the sample is immediately sent to the relevant laboratories to measure interleukin-10 and interleukin-6 factors, and serology tests are measured by the ELISA kit of MabTag GmbH - Germany.In order to evaluate the performance of all three parameters, creatinine level, blood urea nitrogen and glomerular filtration rate (GFR) are checked. In this way, 2 ml of venous blood samples are sent to the relevant laboratory in three time periods before the operation, after entering the ICU and 4 days later, to measure the amount of creatinine, blood urea nitrogen of the kidney. The concentration of blood urea nitrogen and serum creatinine will be determined using an automatic biochemical analyzer (Hitachi 7600, Japan) in the clinical laboratory. The initial GFR of the patient is calculated before taking the Q10 drug, after entering the ICU and 4 days later. Control group: Patients will be divided into two control and intervention groups based on random sampling (permutation blocks). Patients in the intervention group will receive CoQ10 tablets, 300 mg, twice a day every 12 hours, in the period of two days before the operation until the time of discharge from the ICU department and sending to the POST ICU department. Patients in the control group will receive the placebo in the same way, that is, from two days before the operation until the time of discharge from the ICU. Anesthesia induction will be done for all patients with sufentanil 2 µg/kg, nesdonal 3 mg/kg and pancuronium 0.1 mg/kg, and anesthesia will be maintained with 0.5-1% isoflurane and during cardiopulmonary bypass with Pancranium 0.1 mg/kg/h, fentanyl 1-2 µg/kg, and midazolam 0.5-1-1 kg/mg are maintained, and all patients will receive heparin 300 u/kg before cardiopulmonary bypass; until the active coagulation time (ACT) is higher than 480 seconds. . Crystalloid (2000 cc Ringer) and colloid (50 cc albumin) are used to prime the oxygenator in both groups. During CPB, additional heparin will be prescribed to reach the target ACT. After completing CPB and disconnecting from the heparin pump, it is neutralized with protamine sulfate 1 mg per 100 units of heparin; to reach the ACT target of 80-120. In order to measure and evaluate inflammatory factors, 2 ml of arterial blood samples are taken in three time periods at the beginning of the operation, after cardio-pulmonary bypass and 24 hours after entering the ICU. Then, the sample is immediately sent to the relevant laboratories to measure interleukin-10 and interleukin-6 factors, and serology tests are measured by the ELISA kit of MabTag GmbH - Germany.In order to evaluate the performance of all three parameters, creatinine level, blood urea nitrogen and glomerular filtration rate (GFR) are checked. In this way, 2 ml of venous blood samples are sent to the relevant laboratory in three time periods before the operation, after entering the ICU and 4 days later, to measure the amount of creatinine, blood urea nitrogen of the kidney. The concentration of blood urea nitrogen and serum creatinine will be determined using an automatic biochemical analyzer (Hitachi 7600, Japan) in the clinical laboratory. The initial GFR of the patient is calculated before taking the Q10 drug, after entering the ICU and 4 days later. Measurement of interleukin-10 and interleukin-6 factorsIn order to evaluate the performance of all three parameters, creatinine level, blood urea nitrogen and glomerular filtration rate (GFR) are checked. Timepoint: Patients in the intervention group will receive CoQ10 tablets, 300 mg, twice a day every 12 hours, in the period of two days before the operation until the time of discharge from the ICU department and sending to the POST ICU department. Patients in the control group will receive the placebo in the same way, that is, from two days before the operation until the time of discharge from the ICU. Anesthesia induction will be done for all patients with sufentanil 2 µg/kg, nesdonal 3 mg/kg and pancuronium 0.1 mg/kg, and anesthesia will be maintained with 0.5-1% isoflurane and during cardiopulmonary bypass with Pancranium 0.1 mg/kg/h, fentanyl 1-2 µg/kg, and midazolam 0.5-1-1 kg/mg are maintained, and all patients will receive heparin 300 u/kg before cardiopulmonary bypass; until the active coagulation time (ACT) is higher than 480 seconds. . Crystalloid (2000 cc Ringer) and colloid (50 cc albumin) are used to prime the oxygenator in both groups. During CPB, additional heparin will be prescribed to reach the target ACT. After completing CPB and disconnecting from the heparin pump, it is neutralized with protamine sulfate 1 mg per 100 units of heparin; to reach the ACT target of 80-120. In order to measure and evaluate inflammatory factors, 2 ml of arterial blood samples are taken in three time periods at the beginning of the operation, after cardio-pulmonary bypass and 24 hours after entering the ICU. Then, the sample is immediately sent to the relevant laboratories to measure interleukin-10 and interleukin-6 factors, and serology tests are measured by the ELISA kit of MabTag GmbH - Germany.In order to evaluate the performance of all three parameters, creatinine level, blood urea nitrogen and glomerular filtration rate (GFR) are checked. In this way, 2 ml of venous blood samples are sent to the relevant laboratory in three time periods before the operation, after entering the ICU and 4 days later, to measure the amount of creatinine, blood urea nitrogen of the kidney. The concentration of blood urea nitrogen and serum creatinine will be determined using an automatic biochemical analyzer (Hitachi 7600, Japan) in the clinical laboratory. The initial GFR of the patient is calculated before taking the Q10 drug, after entering the ICU and 4 days later. Method of measurement: The following guidelines are used to determine which stage of CKD is most consistent with GFR results:Stage 1 kidney damage with normal kidney function GFR 90 or higherStage 2 mild loss of kidney function GFR 60-89Stage 3A mild to moderate decrease in kidney function GFR 45-59Stage 3B moderate to severe loss of kidney function GFR 30-44Stage 4 severe loss of kidney function GFR 29-15Step 5 - The final stepThe normal range of GFR is usually 90 or more, although it can vary by age. Stage I CKD also has a GFR range of 90 or higher because kidney damage is minimal at this stage. To diagnose CKD caused by surgery, additional tests are done to help diagnose CKD, including: a history of high blood pressure, presence of swelling in the legs, urinary tract infections, and abnormal urine tests (protein in the urine). Also, based on the classification of acute kidney injury, a sudden increase in serum creatinine to 0.3 mg/dL or more (426.4 μmol/L) in 48 hours or an increase in serum creatinine of 50% or more (1.5 times the initial value) or reduction of urine output (oliguria 0.5-1 ml/kg per hour, for 6 hours) will be considered as the first stage of kidney damage.All patients will be transferred to cardiac intensive care unit after surgery and will be mechanically ventilated with simultaneous mandatory intermittent ventilation (SIMV) and pressure support (PS).On the third day after surgery, patients are transferred to the postoperative care unit based on the following criteria: hemodynamic status with acceptable oxygenation and ventilation, conscious level, absence of life-threatening arrhythmias, active bleeding, electrolyte abnormalities, absence Delirium and severe anemia (Hgb <8 g/dL). Before transferring patients, urinary catheter and pericardial drainage tube will be removed. Ghoum University of Medical Sciences Approved 2023-01-27 Ethics committee of Qom University of Medical Sciences Qadir Blvd Pardis University Qom Ghoum Iran (Islamic Republic of)