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IRCT20260731070458N1 IRCT 2026-10-01 Arak University of Medical Sciences Evaluation of the effects of the combination of cardioplegic solution and N-acetylcysteine compared with the combination of cardioplegic solution and vitamin C on the serum level of cardiac troponin after on-pump coronary artery bypass surgery Comparison of the Effect of N-Acetylcysteine and Vitamin C Supplementation of Cardioplegic Solution on Changes in Postoperative Serum Cardiac Troponin Levels Following On-Pump Coronary Artery Bypass Grafting 2026-10-23 anticipated 70 Recruiting https://irct.ir/trial/92820 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization Method: Block randomization Unit of Randomization: Individual participant Description of Randomization Procedure: Given the planned sample size, permuted blocks of four participants will be used. Group 1 will receive vitamin C added to the cardioplegic solution (Group A), whereas Group 2 will receive N-acetylcysteine added to the cardioplegic solution (Group B). For each block of four participants, the six possible allocation sequences are: AABB, BBAA, ABAB, BABA, ABBA, BAAB. One sequence will be selected at random for each block. Before participant enrollment begins, a random allocation list corresponding to the total required sample size will be generated based on these randomly selected block sequences. Randomization Tool and Allocation Concealment: A web-based randomization program will be used to generate the allocation sequence. The program will create randomly permuted treatment assignments for both study groups within each block. Because the order of treatment allocations varies randomly across blocks, allocation concealment will be maintained and the investigator’s ability to predict the treatment assignment of subsequent participants during the study will be minimized. Web-based tool used for random permuted-block allocation: https://www.sealedenvelope.com/simple-randomiser/v1/lists, Blinding description: In this study, the two investigational agents will be prepared by an anesthesiologist in identical syringes of the same color, size, and appearance, according to each patient’s clinical condition. The syringes will be labeled using coded identifiers and provided to the cardiopulmonary bypass (CPB) team for administration. Patients receiving vitamin C added to the cardioplegic solution will be assigned to Group A, while those receiving N-acetylcysteine added to the cardioplegic solution will be assigned to Group B. The patients and the perfusionists responsible for operating the cardiopulmonary bypass machine will remain unaware of the study-group assignments and the contents of the syringes. Only the anesthesiologist, through the syringe coding system, will be aware of the allocated intervention. Furthermore, the cardiac surgeon will be blinded to the treatment allocation and the identity of the administered investigational agent throughout the surgical procedure. Therefore, because the patients, perfusionists, and cardiac surgeon are blinded to the intervention, the study will be conducted as a double-blind clinical trial. N/A On-pump coronary artery bypass grafting. Intervention 1: First intervention group: Participants in this group, designated as Group A, will receive vitamin C at a dose of 50 mg/kg, manufactured by Alborz Pharmaceutical Company, during the initial stages of on-pump coronary artery bypass grafting (CABG). Vitamin C will be administered in combination with, and concurrently with, cold cardioplegic solution.The required dose of cardioplegic solution will be administered after aortic cross-clamping and during the induction of cardiac arrest, as determined by the cardiac surgeon and in accordance with the manufacturer’s recommendations and guidelines provided by Shahid Ghazi Pharmaceutical Company, the manufacturer of the cardioplegic solution. Intervention 2: Second intervention group: Participants in this group, designated as Group B, will receive N-acetylcysteine (NAC) at a dose of 50 mg/kg, manufactured by Exir Pharmaceutical Company, during the initial stages of on-pump coronary artery bypass grafting (CABG). NAC will be administered in combination with, and concurrently with, cold cardioplegic solution.The required dose of cardioplegic solution will be administered after aortic cross-clamp placement and during induction of cardiac arrest, as determined by the cardiac surgeon and in accordance with the recommendations and guidelines of Shahid Ghazi Pharmaceutical Company, the manufacturer of the cardioplegic solution. 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 No further information.
public Ali Jalali Farahani
Floor 3, Morvarid Building, Golestan 15, Allameh Jafari St., Qods Blvd., Arak City.
Arak Iran (Islamic Republic of) 3818160002 +98 86 3368 7782 ali.jalali.9680@gmail.com Arak University of Medical Sciences scientific Alireza Kamali
Deputy for Treatment, Fourth Floor, Arak University of Medical Sciences and Health Services Headquarters, adjacent to Amir Kabir Hospital, Alam al-Hoda Street, Arak, Iran
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 3100 Dr.kamaliarakmu.ac@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Patients scheduled for coronary artery bypass grafting (CABG) who presented to Amir al-Momenin Medical Center in Arak and provided written informed consent to undergo CABG surgery. Patients undergoing open-heart surgery exclusively for CABG, with no indication for concomitant cardiac valve repair or replacement, or cardiac wall reconstruction procedures. Patients who had completed routine preoperative laboratory evaluations and were considered eligible for cardiac surgery, with no contraindications or clinically significant conditions precluding surgery. No history of cerebrovascular accident (CVA). Expected operative duration of 5–6 hours. CABG performed using cardiopulmonary bypass (on-pump CABG). Patients aged 30–75 years. 30 years 75 years Both Performance of concomitant cardiac valve repair or replacement during coronary artery bypass grafting (CABG). Extension of the CABG operative time beyond 6 hours. Requirement for reinstitution of cardiopulmonary bypass during CABG due to the patient’s inability to tolerate separation from cardiopulmonary bypass. I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Treatment - Drugs First intervention group: Participants in this group, designated as Group A, will receive vitamin C at a dose of 50 mg/kg, manufactured by Alborz Pharmaceutical Company, during the initial stages of on-pump coronary artery bypass grafting (CABG). Vitamin C will be administered in combination with, and concurrently with, cold cardioplegic solution.The required dose of cardioplegic solution will be administered after aortic cross-clamping and during the induction of cardiac arrest, as determined by the cardiac surgeon and in accordance with the manufacturer’s recommendations and guidelines provided by Shahid Ghazi Pharmaceutical Company, the manufacturer of the cardioplegic solution. Second intervention group: Participants in this group, designated as Group B, will receive N-acetylcysteine (NAC) at a dose of 50 mg/kg, manufactured by Exir Pharmaceutical Company, during the initial stages of on-pump coronary artery bypass grafting (CABG). NAC will be administered in combination with, and concurrently with, cold cardioplegic solution.The required dose of cardioplegic solution will be administered after aortic cross-clamp placement and during induction of cardiac arrest, as determined by the cardiac surgeon and in accordance with the recommendations and guidelines of Shahid Ghazi Pharmaceutical Company, the manufacturer of the cardioplegic solution. Postoperative serum cardiac troponin levels following on-pump coronary artery bypass grafting. Timepoint: Measurement of serum cardiac troponin levels before surgery (prior to initiation of the intervention) and at 24 and 48 hours after completion of surgery. Method of measurement: Laboratory kits for measuring serum cardiac troponin levels. Arak University of Medical Sciences Approved 2026-04-12 Ethics committee of Arak University of Medical Sciences Research Deputy Building, Payambar-e-Azam University Complex, Basij Square, Sardasht, Arak Arak Markazi Iran (Islamic Republic of)