Evaluation of the Effective Myocardial Protection Duration of Del Nido Cardioplegia: A Prospective Observational Study in Adult Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Intraoperative hs-troponin change-point time (minutes from ACC)
研究概览
简要总结
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.
详细描述
Background and Rationale Del Nido cardioplegia is widely used in adult valve/aortic surgery to permit prolonged single-dose electrical arrest. The effective protection duration likely varies with patient and procedural factors (e.g., LV function, temperature, hemodilution, surgical complexity, antegrade/retrograde delivery). Many centers empirically re-dose around 60-90 minutes; however, this window may not be optimal for every case. The current study quantifies the protection window by coupling routine care with dense, time-stamped hs-troponin sampling.
Design and Setting Prospective, single-center, observational cohort conducted at Necmettin Erbakan University, Department of Cardiovascular Surgery (Türkiye).
Population Adults 18-80 years scheduled for elective valve and/or thoracic aortic surgery under CPB with ACC in which Del Nido cardioplegia is used per institutional routine. Key exclusions include isolated or CABG-dominant procedures, redo sternotomy, emergency/salvage or preoperative shock, IABP/ECMO, LVEF <35%, eGFR <45 mL/min/1.73 m², significant pulmonary or hepatic disease, major coagulopathy, active infection/sepsis or endocarditis, pregnancy, and preoperative troponin elevation.
Interventions None. Cardioplegia content, dose, route (antegrade/retrograde/combined), temperature, and re-dose decisions are entirely per standard practice at the discretion of the surgical/anesthesia/perfusion team. No experimental therapy is administered.
Sampling Schedule (Biomarkers) Preoperative baseline hs-cTn; intraoperative sampling referenced to ACC at 0, 30, and 60 minutes, then intensified at 75, 90, 105, and 120 minutes. If a re-dose is administered, additional samples at pre-re-dose and +15/+30/+45/+60 minutes. Postoperative hs-cTn at approximately 6, 24, and 48 hours. Intraoperative blood is obtained preferably from the venous reservoir or existing central lines. Each draw ~3-5 mL; total additional volume ~30-40 mL. Exploratory CK-MB may be recorded where available.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Intraoperative hs-troponin change-point time (minutes from ACC)
时间窗: 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.
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.
次要结局
- 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)
研究者
Muhammet Talha Ceran, MD
Cardiovascular Surgery Resident, Principal Investigator
Necmettin Erbakan University