Effective Myocardial Protection Time of Del Nido Cardioplegia in Adult Cardiac Surgery
Trial Parameters
Brief Summary
This single-center, prospective, observational cohort study quantifies the effective myocardial protection window of Del Nido cardioplegia during adult open-heart surgery performed under cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC). Without altering routine care, time-stamped high-sensitivity cardiac troponin (hs-cTn) measurements will be obtained at predefined intraoperative and early postoperative intervals to identify the inflection ("change-point") at which biochemical evidence of ischemic injury begins to rise. Eighty adults undergoing elective valve and/or thoracic aortic procedures with Del Nido cardioplegia will be enrolled. The primary endpoint is the intraoperative hs-cTn change-point time referenced to ACC. Secondary endpoints include associations between change-point and ACC duration, the presence/timing of any re-dose, and early clinical outcomes (e.g., low cardiac output syndrome, maximum VIS in the first 24 h, new arrhythmia or pacemaker need, acute kidney injury by KDIGO, ventilation hours, ICU/hospital length of stay, 30-day MACE and mortality). All cardioplegia choices (dose, route, temperature, re-dose decisions) remain per standard practice; no experimental therapy is administered. Risks are minimal and limited to small-volume blood sampling coordinated with routine draws.
Eligibility Criteria
Inclusion Criteria: * Age 18-80 years * Elective valve surgery (aortic, mitral, tricuspid), thoracic aortic surgery, or combined valve + thoracic aortic procedures * Planned cardiopulmonary bypass (CPB) with aortic cross-clamp (ACC) * Use of Del Nido cardioplegia per institutional routine * Ability to provide written informed consent (participant or legally authorized representative) Exclusion Criteria: * Isolated CABG or CABG-dominant combined procedures * Redo sternotomy * Emergency status (including shock) or preoperative mechanical circulatory support (IABP or ECMO), or anticipated need for such support * Left ventricular ejection fraction \<35% * Estimated GFR \<45 mL/min/1.73 m² * Moderate-severe chronic lung disease with significant functional limitation, or severe pulmonary hypertension * Active infection/sepsis or active infective endocarditis * Severe hepatic dysfunction, major coagulopathy, or bleeding diathesis * Pregnancy * Deep hypothermia protocols (\<28 °C) * Procedures