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

NCT07249424 | Completed

• 1 other identifier: E-40209705-050.01-1123786
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Del Nido cardioplegia; cardioplegia; aortic cross-clamp (ACC); high-sensitivity troponin; myocardial protection; cardiopulmonary bypass (CPB); aortic cross-clamp time; single-dose cardioplegia; ischemia-reperfusion; valve surgery; thoracic aortic surgery

Outcome Measures

Primary Outcomes (1)

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

  For each participant, serial hs-cTn values obtained at ACC 0/30/60/75/90/105/120 minutes (and at re-dose pre/+15/+30/+45/+60 when applicable) will be modeled with segmented (piecewise) regression. The change-point is defined as the earliest time with a statistically significant increase in slope indicating evolving myocardial injury. Unit: minutes; lower values reflect earlier loss of protection.

  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.

Secondary Outcomes (4)

• Biochemical response to re-dose (slope change in hs-troponin)

  From re-dose (time 0) to +60 minutes intraoperatively.

• Peak postoperative hs-troponin (0-48 h)

  From end of surgery to 48 hours postoperatively (samples ~6, 24, 48 h).

• Low Cardiac Output Syndrome (LCOS) within 24 hours

  First 24 postoperative hours.

• 30-day major adverse cardiovascular events (MACE)

  30 days after surgery

Other Outcomes (2)

• Association between change-point time and ACC duration

  Intraoperative (from ACC on to 120 min; re-dose window as applicable)

• Immediate reperfusion arrhythmia after ACC removal

  From ACC removal to 30 minutes after reperfusion

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single-center, tertiary academic cardiovascular surgery service at Necmettin Erbakan University Meram Medical Faculty Hospital (Konya, Türkiye). Consecutive adults (18-80 years) undergoing elective valve and/or thoracic aortic surgery with cardiopulmonary bypass and aortic cross-clamping, in whom Del Nido cardioplegia is used as part of routine care, are screened and, if eligible, approached for written informed consent. Approximately 80 participants are enrolled and followed through the index hospitalization; 30-day outcomes are abstracted from the medical record/standard follow-up. Observational cohort; no randomization; all treatment decisions per usual care.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammet Talha Ceran, MD: lead

Study Sites (1)

Necmettin Erbakan University Meram Faculty of Medicine

Konya, Konya, 42080, Turkey (Türkiye)

Location

Related Publications (6)

• Devereaux PJ, Lamy A, Chan MTV, Allard RV, Lomivorotov VV, Landoni G, Zheng H, Paparella D, McGillion MH, Belley-Cote EP, Parlow JL, Underwood MJ, Wang CY, Dvirnik N, Abubakirov M, Fominskiy E, Choi S, Fremes S, Monaco F, Urrutia G, Maestre M, Hajjar LA, Hillis GS, Mills NL, Margari V, Mills JD, Billing JS, Methangkool E, Polanczyk CA, Sant'Anna R, Shukevich D, Conen D, Kavsak PA, McQueen MJ, Brady K, Spence J, Le Manach Y, Mian R, Lee SF, Bangdiwala SI, Hussain S, Borges FK, Pettit S, Vincent J, Guyatt GH, Yusuf S, Alpert JS, White HD, Whitlock RP; VISION Cardiac Surgery Investigators. High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality. N Engl J Med. 2022 Mar 3;386(9):827-836. doi: 10.1056/NEJMoa2000803.

  PMID: 35235725 RESULT

• Ad N,Holmes SD,Massimiano PS,Rongione AJ,Fornaresio LM,Fitzgerald D

  RESULT

• McGrath S, Alaour B, Kampourakis T, Marber M. Cardiac Troponin: Fragments of the Future? JACC Adv. 2025 May;4(5):101695. doi: 10.1016/j.jacadv.2025.101695. Epub 2025 Apr 25.

  PMID: 40286361 RESULT

• Nakao M, Morita K, Shinohara G, Kunihara T. Modified Del Nido Cardioplegia and Its Evaluation in a Piglet Model. Semin Thorac Cardiovasc Surg. 2021 Spring;33(1):84-92. doi: 10.1053/j.semtcvs.2020.03.002. Epub 2020 May 7.

  PMID: 32387781 RESULT

• Januzzi JL Jr. Troponin testing after cardiac surgery. HSR Proc Intensive Care Cardiovasc Anesth. 2009;1(3):22-32.

  PMID: 23439987 RESULT

• Eris C, Engin M, Erdolu B, Kagan As A. Comparison of del Nido Cardioplegia vs. blood cardioplegia in adult aortic surgery: Is the single-dose cardioplegia technique really advantageous? Asian J Surg. 2022 May;45(5):1122-1127. doi: 10.1016/j.asjsur.2021.09.032. Epub 2021 Oct 12.

  PMID: 34649799 RESULT

MeSH Terms

Conditions

Heart Valve Diseases; Aortic Diseases; Myocardial Ischemia; Myocardial Reperfusion Injury; Postoperative Complications

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cardiomyopathies; Reperfusion Injury; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yüksel Dereli, Prof. Dr.

  Necmettin Erbakan University, Dept. of Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

• Muhammet Talha Ceran

  Necmettin Erbakan University, Dept. of Cardiovascular Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiovascular Surgery Resident, Principal Investigator

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: November 12, 2025
• Primary Completion: January 15, 2026
• Study Completion: February 16, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Available beginning 6-12 months after the primary publication (or within 12 months after last-patient-last-visit if no publication) and will remain available for 5 years.
• Access Criteria: Qualified researchers may request access by submitting a brief proposal to the Central Contact. Requests will be reviewed by the study investigators and the institutional Data Access Committee. Upon approval and execution of a Data Use Agreement (non-reidentification, secure storage, academic use only, citation/acknowledgment, and data destruction at project end), de-identified IPD and supporting documents will be transferred via secure link. Central Contact: Muhammet Talha Ceran, MD - mtceran@gmail.com

Locations

TU (1)