Comparing the Myocardial Protection of Custodiol Alone and in Combination with Modified Del Nido in Patients Undergoing Cardiac Surgery; A Double-Blind Randomized Clinical Trial

Background: Coronary Artery Bypass Grafting (CABG) has been considered as the complete treatment of Ischemic Heart Disease (IHD). Cardioplegic (extracellular and intracellular) solutions have been suggested to reduce the cross-clamping duration. It was hypothesized that the combination of the two intra- and extra-cellular solutions, namely Del Nido (DN) and custodiol, could result in beneficiary clinical and economic outcomes. Objectives: The present study aimed to compare the myocardial protection of custodiol alone and in combination with modified DN in patients undergoing cardiac surgery. Methods: This prospective, double-blind, clinical trial was conducted on 50 patients undergoing redo CABG surgery. Aortic clamping was performed using custodiol (20 cc/kg) in group A. In group B, custodiol 1000 cc was combined with 15 cc/kg cold DN and was injected using the antigrade method. The two groups were compared regarding the levels of Creatinine Kinase-MB (CK-MB) and troponin at the time of anesthesia induction and two hours and 48 hours after the surgery, intraoperative and postoperative variables, and 48–hour mortality rate. Results: The results showed similar CK-MB levels in the two groups at the induction time (P = 0.12). However, a significant difference was observed between the two groups in this regard two hours (P = 0.018) and 48 hours after the surgery (P = 0.021). Within-group comparisons revealed significant changes in CK-MB and troponin levels in both groups, with a steep increase from induction until two hours after the surgery and a decrease from two hours until 48 hours after the surgery (P < 0.001). The results indicated no significant difference between the two groups regarding CK-MB and troponin levels, frequency of intraoperative and postoperative dysrhythmia, need for intraoperative defibrillation, ischemic time, and 48-hour mortality rate (P > 0.05). However, the costs were two-folds higher in group A than in group B (P < 0.001). Conclusions: The present study findings showed that the selected solution was appropriate in terms of clinical aspects for the patients undergoing CABG surgery with long surgical duration or low Ejection Fraction (EF) and reduced the costs to half. Considering the significant difference in the CK-MB level and the lower troponin level in the combined group (not statistically significant), further studies are required to confirm the clinical priority of the combined solution.