Study of Myocardial Microcirculatory Alterations in Patients With Sepsis and Septic Shock Using Myocardial Contrast Echocardiography (MCE)
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean change of the time to Peak intensity (TTP) from baseline (seconds).
研究概览
简要总结
Myocardial microcirculatory alterations may be involved in the pathogenesis of acute cardiac dysfunction or septic cardiomyopathy in septic patients. The investigators study the cardiac function (systolic and diastolic) with two-dimensional echocardiography (TTE), and the myocardial microcirculation with contrast echocardiography (MCE) and sulphur hexafluoride microbubbles Sonovue injection in ICU septic patients.
详细描述
Using the IE33 device (Philips Medical Systems, the Netherlands), two-dimensional and myocardial contrast echocardiography (TTE and MCE) are performed following the recommendations of the American Heart Association and the European Society of Cardiology (2006), and the European Association of Cardiovascular Imaging (2017). TTE and MCE are performed at the same time in the first 24 hours after ICU admission, at 48-72 hours, at 5-10 days after withdrawal of vasopressors and inotropes.
First, TTE evaluates from the apical and parasternal views:
- The Wall motion score index (WMSI) of 16 myocardial segments of the left ventricle (LV).
- The diastolic function using pulsed-wave doppler and pulsed tissue doppler at the mitral valve.
- Quantify valvular insufficiency
- Estimation of cardiac output (L/ minute).
- Evaluation of the right ventricle (RV) dimension and its the longitudinal contractility by the Tricuspid annular plane systolic excursion (TAPSE) with pulsed tissue doppler.
- Left atrial volume (ml).
- Systolic pulmonary pressure and pulmonary resistance with both continuous and pulsed-wave doppler at the tricuspid valve and the pulmonary outflow tract, respectively.
Second, MCE is performed if:
- Systolic blood pressure < 200 mmHg or > 90 mmHg,
- Heart rate < 130 or > 50 beats/minute
- Peripheral pulse oxygen saturation > 90%
- Arterial oxygen partial pressure (PaO2) ≥ 70 mmHg
- Arterial pH ≥ 7.25.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sepsis: a life-threatening organ dysfunction (defined as an acute change in total Sequential Organ Failure Assessment (SOFA) score > 2 points consequent to infection) caused by a dysregulated host response to infection.
- •Sepsis shock : a subset of sepsis with persisting hypotension requiring vasopressors to maintain the mean arterial pressure > 65 mmHg and having a serum lactate level > 2 mmol/L after fluid resuscitation.
排除标准
- •Non-survivors in the first 24 hours from sepsis
- •Sepsis post-acute cardiac arrest
- •Pregnancy
- •Younger than 18 years old
- •Acute Respiratory Distress Syndrome (ARDS) with the ratio of arterial oxygen partial pressure (mmHg) to fractional inspired oxygen (PaO2/ FiO2) < 200)
- •Advanced malignancy
- •Untreated and unstable acute coronary syndrome
- •History of myocardial infarction with severe left ventricular dysfunction. (Ejection fraction < 20 %).
- •Inoperable valvular and coronary disease
- •Significant right-left cardiac shunt
- •Untreated congenital heart disease
- •Severe systolic pulmonary hypertension > 80 mmHg
- •Insufficient echogenicity
- •Prior anaphylaxis reaction to the Sonovue microbubbles
结局指标
主要结局
Mean change of the time to Peak intensity (TTP) from baseline (seconds).
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a prolonged time to Peak intensity over time.
Mean change of the Peak intensity (PI) from baseline (seconds).
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a reduced Peak intensity over time
Mean change of the ejection fraction from baseline (%)
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Quantitative evaluation of the global LV ejection fraction using the Simpson method. The investigators expect a lower ejection fraction than 50% in patients who develop cardiac dysfunction over time.
Mean change of the Wall motion score index (WMSI) from baseline (normal score: 32)
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Quantitative evaluation of the regional contractility of 16 myocardial segments of LV using the Wall motion score index. The investigators expect a lower score than 32 in patients who develop cardiac dysfunction over time
Mean change of the Mean transit time (MTT) from baseline (seconds)
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a prolonged Mean transit time over time.
Mean change of the Area under the curve (AUC) from baseline (dB/ seconds).
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Qualitative evaluation of myocardial microcirculation using the variables of the time-intensity curve after Sonovue administration: The investigators hypothesize that patients who develop cardiac dysfunction will have a reduced Area under the curve (AUC) over time
Mean change of the Tricuspid annular plane systolic excursion (TAPSE) of the right ventricle from baseline (mm)
时间窗: Comparison to baseline (24 hours after ICU admission) to the two other time points: at 48 to 72 hours, at 5 to 10 days after withdrawal of vasopressor and inotropic agents.
Quantitative evaluation of the longitudinal contractility of the right ventricle by measuring the Tricuspid annular plane systolic excursion (TAPSE) with pulsed tissue doppler. The investigators expect lower values than 15 mm in patients who develop cardiac dysfunction over time.
次要结局
- Mean change of biomarker of cardiac injury: serum High sensitivity cardiac troponin I (micrograms/ L) from baseline.(Comparison to baseline (24 hours after ICU admission) and then once daily during the study period)
- Mean change of biomarker of heart failure: serum N-terminal pro-brain natriuretic peptide (NT-proBNP) (nanograms/ L) from baseline.(Comparison to baseline (24 hours after ICU admission) and then once daily during the study period)
研究者
Duc Nam Nguyen
Clinical Professor
Universitair Ziekenhuis Brussel