This clinical trial is focused on patients undergoing major cardiac surgery that requires the use of a heart-lung machine, known as extracorporeal circulation. The study aims to evaluate the effects of two different solutions used to protect the heart during surgery, called cardioplegia. The two solutions being compared are CUSTODIOL® and Cardi-Braun Mantenimiento. These solutions contain various substances, such as mannitol, tryptophan, magnesium chloride, and glucose, which help in maintaining the heart’s condition during the procedure.
The purpose of the study is to determine if CUSTODIOL® is not inferior to another type of cardioplegia known as Buckberg blood cardioplegia. Patients will receive either CUSTODIOL® or Cardi-Braun Mantenimiento during their surgery. The study will monitor the patients for 90 days after the surgery to observe any major health events, such as heart attacks, kidney failure, or the need for medications to support heart function. Additionally, the study will look at other factors like the need for blood transfusions, the duration of mechanical ventilation, and any neurological complications.
Participants in the study will be closely monitored for any changes in their health, including the levels of a heart-related protein called Troponin I at 12 and 24 hours after surgery. The study will also compare the overall survival rates and the occurrence of conditions like atrial fibrillation, which is an irregular heartbeat, within 90 days post-surgery. This research aims to provide valuable insights into the best practices for protecting the heart during major cardiac surgeries.



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