CompletedNot Applicable

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

Turkey (Türkiye)80 participantsStarted 2025-11-12

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intraoperative hs-troponin change-point time (minutes from ACC)

Timeframe: From aortic cross-clamp (ACC) application to 120 minutes intraoperatively; if a re-dose is given, up to 60 minutes after the re-dose within the same operation.

Trial details

NCT IDNCT07249424

SponsorMuhammet Talha Ceran, MD

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-01-15

View on ClinicalTrials.gov More Heart Valve Diseases trials