Respiratory Variations of the Inferior Vena Cava and Femoral Artery Flow to Predict Fluid Responsiveness in Spontaneously Breathing Patients With Sepsis, Acute Circulatory Failure, and Regular Cardiac Rhythm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- "respiratory variations in inferior vena cava diameters" with respect to the response to fluid resuscitation, assessed by the area under the ROC curve
研究概览
简要总结
Hypovolemia and acute circulatory failure affects more than 60% of patients hospitalized in intensive care or resuscitation. The volume expansion (VE) by fluid replacement therapy is the first treatment improve circulatory function. However, too much VE can be harmful. So, the use of dynamic predictive indicators of fluid responsiveness is recommended in patients with sepsis.In patients with spontaneous ventilation, few studies have evaluated these parameters. In mechanical ventilation, indices based on the respiratory variation of the diameters of vena cava have been studied and validated to predict the response to VE. However there is no similar study in spontaneously breathing patients without ventilatory support. The investigators hypothesize that the respiratory variations in the IVC diameters and femoral artery flow during standardized respiratory cycles are predictive factors of fluid responsiveness in spontaneously breathing patients with sepsis, acute circulatory failure, and regular cardiac rhythm.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of the intensive care units of the Lille university-hospital and of the Valenciennes general hospital.
- •Age greater than or equal to
- •Patient insured
- •Spontaneous breathing without ventilatory support or intubation or tracheotomy.
- •Regular cardiac rhythm
- •Prescription by the physician in charge of the patients of a 500 mL volume expansion in less than 30 minutes.
- •Patients with sepsis with at least one sign of acute circulatory failure:
- •Tachycardia with heart rate> 100/min
- •systolic blood pressure <90mmHg or a decrease >40mmHg in previously hypertense patient
- •Oliguria <0.5ml/kg/hour for at least one hour
- •skin mottling
排除标准
- •high-grade aortic insufficiency
- •transthoracic echogenicity unsuitable for measuring the stroke volume or inferior vena cava diameters
- •clinical signs of active exhalation
- •clinical or ultrasonographic evidence of pulmonary edema due to heart failure
- •pregnancy
- •abdominal compartment syndrome
- •Irregular cardiac rhythm
研究组 & 干预措施
Echocardiography-Doppler
Ultrasonographic recordings, systemic arterial pressure, heart rate, and respiratory rate are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin. Inferior Vena Cava diameters are measured during spontaneous and standardized respiratory cycles. Stroke volume is measured during spontaneous respiratory cycles.
干预措施: Echocardiography-Doppler (Other)
结局指标
主要结局
"respiratory variations in inferior vena cava diameters" with respect to the response to fluid resuscitation, assessed by the area under the ROC curve
时间窗: during 30 minutes of the volume expansion
次要结局
- "respiratory variations the femoral artery flow" with respect to the response to fluid resuscitation, assessed by the area under the ROC curve(during 30 minutes of the volume expansion)