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

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.

NCT Number	NCT07249424
Lead Sponsor	Muhammet Talha Ceran, MD
Conditions	Heart Valve Diseases, Aortic Diseases, Myocardial Ischemia, Reperfusion Injury, Myocardial, Postoperative Complications (Cardiopulmonary), Cardiopulmonary Bypass
Enrollment	80 participants
Start Date	2025-11-12
Primary Completion	2026-01-15 (estimated)
Study Completion	2026-02-16 (estimated)
Updated on ClinicalTrials.gov	2026-04-13