Effective Myocardial Protection Time of Del Nido Cardioplegia in Adult Cardiac Surgery
Evaluation of the Effective Myocardial Protection Duration of Del Nido Cardioplegia: A Prospective Observational Study in Adult Patients Undergoing Cardiac Surgery
Muhammet Talha Ceran, MD
80 participants
Nov 12, 2025
OBSERVATIONAL
Conditions
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 Criteria5
- 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 Criteria13
- 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
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07249424