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

NCT07249424 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Heart Valve Diseases
  • Aortic Diseases
  • Myocardial Ischemia
  • Reperfusion Injury, Myocardial
  • Postoperative Complications (Cardiopulmonary)
  • Cardiopulmonary Bypass

Sponsors & Collaborators

  • Muhammet Talha Ceran, MD

    lead OTHER

Principal Investigators

  • Yüksel Dereli, Prof. Dr. · Necmettin Erbakan University, Dept. of Cardiovascular Surgery

  • Muhammet Talha Ceran · Necmettin Erbakan University, Dept. of Cardiovascular Surgery

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-12
Primary Completion
2026-01-15
Completion
2026-02-16

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07249424 on ClinicalTrials.gov