Global Longitudinal Strain as a Predictor of Difficult Separating From Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- To evaluate the predictive value of GLS measurements for difficult separation from cardiopulmonary bypass.
研究概览
简要总结
The goal of this observational study is to learn whether global longitudinal strain (GLS), measured by echocardiography, can predict difficulty separating from cardiopulmonary bypass (CPB) in adults undergoing elective cardiac surgery.
The main questions it aims to answer are:
- Can preoperative GLS measurement predict difficult separation from CPB?
- Are GLS values associated with outcomes such as intensive care unit (ICU) stay, hospital stay, cardiac biomarkers, or 30-day mortality?
Participants will:
- Undergo standard cardiac surgery requiring CPB
- Have echocardiographic assessments (TTE before and after surgery)
- Have their recovery and outcomes monitored, including ICU and hospital stay, postoperative labs, and survival within 30 days
详细描述
Background and Rationale
Difficult separation from cardiopulmonary bypass (CPB) is a serious intraoperative complication associated with increased perioperative morbidity and mortality. Myocardial contractility is the key determinant of successful CPB separation, and perioperative echocardiography is an established method for evaluating ventricular function. Conventionally, left ventricular ejection fraction (LVEF) measured by Simpson's biplane method is used to assess myocardial performance. However, LVEF has notable limitations, including high inter-operator variability, preload/afterload dependence, and poor sensitivity in detecting early myocardial dysfunction.
Global longitudinal strain (GLS), measured by two-dimensional speckle-tracking echocardiography, has emerged as a sensitive, reproducible, and geometry-independent parameter of myocardial function. GLS can detect subtle ventricular dysfunction earlier than conventional LVEF and has demonstrated prognostic value in a variety of clinical settings. Despite this, its use in the perioperative cardiac surgery population remains limited, partly due to uncertainty about the optimal timing of assessment. Anesthesia induction, CPB, and myocardial protection strategies may alter myocardial performance, and therefore both absolute GLS values and dynamic perioperative changes may carry prognostic significance.
Study Objectives
The primary objective of this prospective, multicenter, observational study is to evaluate the predictive value of GLS measurements for difficult separation from CPB. Specifically, the study will assess whether GLS measured by preoperative transthoracic echocardiography (TTE) can independently predict the need for multiple inotropic/vasoactive agents during CPB weaning.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Scheduled for elective cardiac surgery requiring cardiopulmonary bypass (CPB).
- •Provided written informed consent to participate.
- •Eligible surgical procedures include:
- •Isolated mitral valve replacement or repair.
- •Isolated aortic valve replacement or repair.
- •Isolated coronary artery bypass grafting (CABG).
- •Combined valve and CABG surgery.
- •Multiple valve replacement or repair.
- •Surgery involving the ascending aorta or aortic arch.
排除标准
- •Emergency cardiac surgery.
- •Redo cardiac surgery.
- •Contraindications to transesophageal echocardiography (TEE).
- •Critical preoperative conditions, including:
- •Ongoing inotropic drug therapy.
- •Preoperative mechanical circulatory support (e.g., IABP, ECMO, VAD).
- •Requirement for mechanical ventilation.
- •Preoperative atrial fibrillation.
研究组 & 干预措施
Easy CPB Separation
Easy separation from CPB was defined as no pharmacologic support or use of a single agent (either vasoactive or inotropic).
干预措施: Myocardial strain imaging (Diagnostic Test)
Difficult CPB Separation
Difficult CPB separation can be defined as the need of at least 2 inotropes or vasopressors to successfully accomplish the separation from CPB.
干预措施: Myocardial strain imaging (Diagnostic Test)
结局指标
主要结局
To evaluate the predictive value of GLS measurements for difficult separation from cardiopulmonary bypass.
时间窗: perioperative
Separating from CPB was categorized as easy and difficult separation from CPB. Easy separation from CPB was defined as no pharmacologic support or use of a single agent (either vasoactive or inotropic). Difficult CPB separation can be defined as the need of at least 2 inotropes or vasopressors to successfully accomplish the separation from CPB
次要结局
- To assess the associations between strain imaging and ICU/hospital length of stay, postoperative trajectories of cardiac biomarkers, and all-cause mortality.(Post operative 30 days)
研究者
mustafa emre gürcü
Attending Medical Doctor
Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
