Changes in Pulse Pressure Variations Induced by Passive Leg Raising Test to Predict Fluid Responsiveness in ICU
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 286
- 试验地点
- 12
- 主要终点
- Increase in cardiac output in all mechanically ventilated patients
研究概览
简要总结
The passive leg raising (PLR) test is a reversible preload challenge of around 300 mL of blood that can be repeated as frequently as required without infusing a drop of fluid. Two recent meta-analyses of many studies have confirmed the reliability of the PLR test to predict fluid responsiveness in patients with acute circulatory failure. Nevertheless, the effects of the PLR must be assessed by the direct measurement of cardiac output since changes in arterial pressure do not allow the assessment of the PLR hemodynamic effects with reliability. Moreover, cardiac output must be measured continuously and in real time.
In clinical practice, cardiac output measurement can be difficult for different reasons such as the unavailability of the echocardiography machine, or the absence of any continuous cardiac output monitoring technique at the time of acute circulatory failure occurrence.
Recently, it was shown that the decrease in pulse pressure variation (PPV) induced by the mini-fluid challenge (100 mL of colloid solution infused in 1 min) was able to predict fluid responsiveness with reliability in patients ventilated with low tidal volume (<8 mL/kg of ideal body weight).
Therefore, the investigators hypothesize that the changes in PPV induced by PLR test could be able to predict fluid responsiveness with reliability in mechanically ventilated patients with acute circulatory failure.
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
- •Mechanically ventilated patients
- •Patients in whom the physician decides to perform a fluid challenge based on the presence of one of the following criteria:
- •(1) systolic arterial pressure <90 mmHg, mean arterial pressure <65 mmHg, or the need for vasopressor infusion; (2) skin mottling; (3) urine output <0.5 mL/Kg/h for more than or equal to 2 hours; (4) lactate concentrations > 2 mmol/L
- •Patients in whom the physician decides to perform a PLR test to predict fluid responsiveness
- •Arterial catheter should be in place for invasive monitoring of arterial pressure and PPV
- •Non inclusion Criteria:
- •Age <18 yrs
- •Pregnancy
- •Moribund patients
- •Risk of fluid loading induced pulmonary edema
- •Cardiac arrhythmias
- •Contraindication to perform PLR (intracranial hypertension, pelvic fractures)
- •Exclusion Criteria :
- •Changes in vasopressor and sedation agents dosages during the protocol
- •Changes in ventilatory parameters during the protocol
排除标准
- 未提供
结局指标
主要结局
Increase in cardiac output in all mechanically ventilated patients
时间窗: Cardiac output will be measured immediately after the end of the volume expansion
The primary endpoint is the increase in cardiac output of more than or equal to 15% after 500 mL of volume expansion. All included patients are concerned by the primary outcome.
次要结局
- Increase in cardiac output in mechanically ventilated patients with low tidal ventilation and/or low respiratory compliance(Cardiac output will be measured immediately after the end of the volume expansion)
- Increase in cardiac output in mechanically ventilated patients with spontaneous breathing activities(Cardiac output will be measured immediately after the end of the volume expansion)