Cardiac Cycle Efficiency and Vasoactive-Inotropic Support After Cardiac Surgery (CCE-VIS)
The Value of Cardiac Cycle Efficiency After Cardiopulmonary Bypass in Predicting Vasoactive-Inotropic Support Requirement (VIS) in the First 24 Hours in Open-Heart Surgery: A Prospective Observational Cohort Study
This study aims to find out whether Cardiac Cycle Efficiency (CCE), measured with the MostCare Up monitor 30 minutes after coming off cardiopulmonary bypass, can predict which adult patients will need high doses of vasoactive and inotropic drugs (maximum Vasoactive-Inotropic Score ≥15) in the first 24 hours after open-heart surgery. No additional procedures or treatments will be applied; data will be collected from the routinely placed arterial catheter.
研究概览
详细说明
After open-heart surgery with cardiopulmonary bypass (CPB), many patients develop myocardial depression and vasoplegia and require vasoactive and inotropic support. High support requirement, quantified by the Vasoactive-Inotropic Score (VIS), is associated with prolonged mechanical ventilation, acute kidney injury, longer ICU stay and increased mortality. Reliable early hemodynamic markers to identify these patients are lacking.
Cardiac Cycle Efficiency (CCE), derived from arterial waveform analysis by the Pressure Recording Analytical Method (MostCare Up), reflects the energetic efficiency of the cardiovascular system, integrating contractility, arterial load and ventricular-arterial coupling. Lower CCE values have been associated with higher inotropic requirement in children after cardiac surgery, but data in adults are lacking.
In this single-center prospective observational study, hemodynamic parameters will be recorded at six time points: after induction, before CPB, 15 and 30 minutes after separation from CPB, end of surgery, and ICU admission. Patients will be classified according to maximum VIS in the first 24 postoperative hours (<15 vs ≥15). The predictive performance of CCE at 30 minutes after CPB will be assessed by ROC analysis. Associations of CCE with lactate, duration of mechanical ventilation, ICU and hospital stay, acute kidney injury and in-hospital mortality will also be evaluated.
研究类型
注册 (估计的)
联系人和位置
学习地点
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Bursa
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Nilufer、Bursa、土耳其(türkiye)、16110
- 招聘中
- Bursa City Hospital
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接触:
- emre ulusoy
- 电话号码:05379492799
- 邮箱:emreulusoy36@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adult patients undergoing elective open-heart surgery with cardiopulmonary bypass at Bursa City Hospital.
描述
Inclusion Criteria:
- Age 18 years or older
- ASA physical status II-IV
- Elective coronary artery bypass grafting, valve surgery, or combined CABG and valve surgery with cardiopulmonary bypass
- Written informed consent
Exclusion Criteria:
- Emergency surgery
- Preoperative mechanical circulatory support (IABP, ECMO, Impella, etc.)
- Permanent pacemaker dependency
- Severe arrhythmia (uncontrolled atrial fibrillation, ventricular arrhythmia, etc.)
- Redo cardiac surgery
- Aortic dissection
- Pregnancy
- Unreliable arterial pressure waveform
- Need for IABP, ECMO, or temporary epicardial pacing during weaning from bypass or during surgery
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
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Adult Open-Heart Surgery Patients
Adult patients undergoing elective coronary artery bypass grafting, valve surgery, or combined surgery with cardiopulmonary bypass. Hemodynamic parameters including Cardiac Cycle Efficiency will be recorded with the MostCare Up system via the routinely placed radial arterial catheter. No study-specific intervention will be applied. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Predictive Performance of CCE for High Vasoactive-Inotropic Support
大体时间:First 24 hours after ICU admission
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Area under the ROC curve of Cardiac Cycle Efficiency measured 30 minutes after separation from cardiopulmonary bypass for predicting maximum Vasoactive-Inotropic Score (VISmax) ≥15. VISmax is the highest hourly VIS during the first 24 hours after ICU admission. |
First 24 hours after ICU admission
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Predictive Performance of Early CCE (T3 and Mean T3-T4)
大体时间:First 24 hours after ICU admission
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ROC analysis of CCE at 15 minutes after bypass and mean of 15- and 30-minute CCE values for predicting VISmax ≥15. |
First 24 hours after ICU admission
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Vasoactive-Inotropic Score
大体时间:24 hours
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VIS at ICU admission, 6 hours and 24 hours after ICU admission. |
24 hours
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Serum Lactate and Lactate Clearance
大体时间:24 hours
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Lactate (mmol/L) at ICU admission, 6 and 24 hours; lactate clearance in the first 6 hours (%). |
24 hours
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In-Hospital Mortality
大体时间:Until hospital discharge, up to 30 days
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All-cause death during hospital stay. |
Until hospital discharge, up to 30 days
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Duration of Mechanical Ventilation
大体时间:Until hospital discharge, up to 30 days
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Time from ICU admission to extubation (hours) and need for reintubation. |
Until hospital discharge, up to 30 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- BSH0003
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