NCT01673230已完成不适用
Hemodynamic Indices Predictive of a Beneficial Response to Fluid Expansion in Case of Hemodynamic Failure After Cardiac Surgery With Altered Preoperative Ejection Fraction (LVEF≤45%): Sensibility and Specificity of Respiratory Variations of Pulse Pressure (∆PP), Photoplethysmography (∆POP), Perfusion Index (PVI), Before and After Fluid Expansion.
Rennes University Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)
研究概览
简要总结
Low Cardiac Output Syndrome occurs frequently after cardiac surgery, especially when pre-operative LVEF is altered (LVEF≤45%). The correction of hemodynamic failure requires adapted treatments: fluid expansion and/or inotropic or vasoactive drugs. Predictive indices of a response to fluid challenge may allow an earlier hemodynamic optimization, which has not been showed until now when LVEF is altered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •patients >18 years old in the immediate post-operative period after cardiac surgery
- •ASA 1 - 3
- •Pre-operative LVEF≤45%
- •Sedated with Ramsay score: 6
- •Mechanically ventilated with tidal volume at 8ml/kg, PEEP at 0mmHg, I/Eat 0,5
- •With hemodynamic failure: SAP≤90mmHg and/or inotropic or vasoactive drug started in the operating room and/or clinical sign of shock and/or CI ≤2,3l/min/m2
- •Affiliation to Health Insurance
- •Consent form signed
排除标准
- •Cardiac arrhythmia: frequent atrial or ventricular extra systoles, atrial fibrillation
- •Intracardiac shunt
- •Weight less than 50 kg
- •History of central nervous system illness
- •Pulmonary oedema (clinical and/or radiological and/or wedge pressure>18mmHg)
- •Right ventricular failure suspected (CVP> wedge pressure) or diagnosed (trans thoracic and/or transesophageal echocardiography)
- •Acute kidney injury with oligoanuria
- •Severe post operative bleeding (chest tubes volume of >200ml/h for 3 hours or more)
- •Severe hypoxia (PaO2/FIO2< 100)
- •Administrative control (patient under guardianship or curatorship)
结局指标
主要结局
Measure of ∆PP, ∆POP, PVI and Cardiac index (CI)
时间窗: 2 hours
To assess the sensibility and specificity of ∆PP, ∆POP, PVI, after fluid expansion in case of hemodynamic failure in the immediate post-operative period after cardiac surgery, when pre-operative LVEF is altered.
次要结局
- Measure of Systolic, diastolic and mean arterial pressure (SAP, DAP, MAP), Central venous pressure (CVP) and wedge pressure.(2 hours)
研究者
研究点 (2)
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