Effective Myocardial Protection Time of Del Nido Cardioplegia in Adult Cardiac Surgery

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

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 without ACC
* Preoperative cardiac troponin above the laboratory upper reference limit
* Any condition that, in the judgment of the treating team, would preclude safe participation or protocol adherence

Conditions7

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