Mini Bolus for Fluid Challenge Responsiveness in the Emergency Department
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Measurement of the cardiac flow with the Estimate Continuous CO escco and SVescco (EsCCO) to predict the fluid responsiveness .
研究概览
简要总结
Intravascular volume expansion is a common intervention in critically ill patients with acute circulatory failure.we test the hypothesis that a mini-bolus fluid challenge, of either 50 ml , can predict fluid responsiveness in spontaneously breathing patients with hemodynamic instability.
详细描述
Background:
Intravascular volume expansion is a common intervention in critically ill patients with acute circulatory failure. Nevertheless, approximately 50% of critically ill patients will not benefit from an intravascular volume expansion, since they are in the horizontal portion of the Frank-Starling curve.
Thus, an accurate assessment of fluid responsiveness prior to volume expansion is mandatory to avoid fluid overload, which has been associated with increased morbidity and mortality in critically ill patients.
Fluid challenge, which consists of administering fluid to assess volume responsiveness, is widely performed. However, repeated fluid challenges, several times a day, can be harmful Indeed, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading can compromise micro-vascular perfusion and oxygen delivery or aggravate peripheral and pulmonary oedema.
For many years, spontaneous breathing was considered a major limitation to assess fluid responsiveness in critically ill patients .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with spontaneous breathing
- •Patients in whom a fluid challenge is indicated because they present acute circulatory failure (which is defined as systolic blood pressure less than 90 mmHg or the need for vasopressors (norepinephrine more than 0.1 µg/kg/min) to maintain a systolic blood pressure more than 90 mmHg (14), and at least one sign of inadequate tissue perfusion:
- •urine output of below 0.5ml/kg per hour over 1 hour
- •tachycardia (heart rate of greater than 100 beats per minute)
- •mottled skin.
- •lactate > 2 mmol/l
排除标准
- •Cardiac arrest
- •Acute respiratory distress syndrome
- •Coma Glasgow Scale < 14
- •Age of less than 18 years
- •Moribund patients
- •Pregnant patients
- •impossibility to perform passive leg raising (PLR) (trauma patients, lower extremity amputees, and prone patients)
- •Patients with cardiac arrhythmias
- •Patients with cardiogenic pulmonary oedema
结局指标
主要结局
Measurement of the cardiac flow with the Estimate Continuous CO escco and SVescco (EsCCO) to predict the fluid responsiveness .
时间窗: at 3 minutes following fluid load in the day of admission
Predicting fluid responsiveness in spontaneously breathing patients with hemodynamic instability.
次要结局
未报告次要终点
研究者
Pr. Semir Nouira
Head chief, Emmergency Department ,University Hospital of Monastir
University of Monastir