Study Comparing Custodiol Crystalloid and Buckberg Blood Cardioplegia in Adults Undergoing Major Cardiac Surgery with Extracorporeal Circulation

What this Trial Is About

Researchers are evaluating the effects of two types of cardioplegia solutions used during major cardiac surgery with extracorporeal circulation. This Phase IV clinical trial compares Custodiol crystalloid cardioplegia and Buckberg blood cardioplegia to determine if Custodiol is not inferior to Buckberg in protecting the heart during surgery with prolonged aortic clamping times. The study aims to address the lack of standardized consensus on the best cardioplegia strategy for different cardiac procedures. Participants will be randomly assigned to receive either Custodiol crystalloid cardioplegia or Buckberg blood cardioplegia during their cardiac surgery. Both treatments are widely used and considered safe, but this study prospectively compares their clinical impact in a controlled setting. The trial is single-blind and will focus on patients undergoing complex cardiac surgeries requiring extracorporeal circulation. During the study, patients will be monitored closely for outcomes including a composite event measured 90 days after surgery. Researchers will assess differences in heart damage markers like Troponin levels, mortality rates, cardiac output, kidney function, myocardial infarction, bleeding, need for transfusion, mechanical ventilation duration, neurological complications, atrial fibrillation, and overall survival at 90 days. The total participation period covers these 90 days post-intervention to evaluate recovery and safety.

Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.