Evaluation of the Effective Myocardial Protection Duration of Del Nido Cardioplegia: A Prospective Observational Study in Adult Patients Undergoing Cardiac Surgery

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Turkey
Necmettin Erbakan University Meram Faculty of Medicine
RECRUITING
Konya
Contact Information
Primary
Muhammet Talha Ceran
mtceran@gmail.com
+905426880431
Backup
Yüksel Dereli
hastane@erbakan.edu.tr
+903322236861
Time Frame
Start Date: 2025-11-12
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 80
Treatments
Del Nido Cardioplegia Cohort
Adults undergoing elective valve and/or thoracic aortic surgery under CPB with ACC in which Del Nido cardioplegia is used per routine practice. No experimental therapy; only study-specific blood sampling for hs-troponin at predefined times.
Related Therapeutic Areas
Sponsors
Leads: Muhammet Talha Ceran, MD

This content was sourced from clinicaltrials.gov