NCT07249424Completed

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

Source: ClinicalTrials.gov · Last updated 13 Apr 2026

Brief summary (registry, in English)

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.

Status (registry): Completed
Study type: Observational
Enrollment: 80 (actual)
First submitted: 18 Nov 2025
Start date: 12 Nov 2025
Primary completion date: 15 Jan 2026
Lead sponsor: Muhammet Talha Ceran, MD
NCT number: NCT07249424

What you commit to

Study type: Observational
Participants enrolled: 80
From 12 Nov 2025 to the primary completion date, 15 Jan 2026
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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
Any condition that, in the judgment of the treating team, would preclude safe participation or protocol adherence

Lab values

Left ventricular ejection fraction \<35%
Estimated GFR \<45 mL/min/1.73 m²
Preoperative cardiac troponin above the laboratory upper reference limit

Other

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
Pregnancy
Deep hypothermia protocols (\<28 °C)
Procedures without ACC

Who the study is looking for

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)

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Necmettin Erbakan University Meram Faculty of Medicine Coordinator of this site? Confirm its status	Konya	Turkey (Türkiye)	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.