Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination - "FRIEND Study"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Fluid responsiveness
研究概览
简要总结
The study aims at clarification of venous collapsibility measures with real venous flow measurements during dynamic maneuver testing fluid responsiveness in septic shock patients.
详细描述
Sedated and mechanically ventilated patients in septic shock will be enrolled in the study. A fine catheter with ultrasound doppler probe will be introduced into the central venous catheter already in place in superior vena cava. Doppler signal will be evaluated by console prototype (NILUS Medical) and continuous analysis of blood flow velocity respiratory variation will be performed. These values will be compared to standard hemodynamic monitoring parameters (central venous and arterial pressures) and to parameters acquired by transoesophageal (TOE) and transthoracic echocardiography.
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
- •patients in severe sepsis or septic shock
- •intubation and mechanical ventilation
- •sedated patient without spontaneous respiratory efforts
- •central venous catheter in place inserted via right internal jugular vein
- •signed informed consent by family members
排除标准
- •superior vena cava vascular anomaly
- •irradiation of neck or mediastinum in medical history
- •thrombosis of superior vena cava in medical history
- •atrial fibrillation or other irregular rhythm
- •permanent or external pacemaker
- •aggressive mechanical ventilation (PEEP above 10 cm H2O, Pmax above 30 cm H2O)
- •TOE contraindication (oesophageal varices, stricture, tumour, upper gastrointestinal bleeding)
- •Pericardial effusion, constrictive pericarditis
- •Moderate or severe valvular lesion
- •Severe systolic dysfunction of the left (EF less than 30%) or right ventricle (FAC less than 25%)
- •Intraabdominal pressure above 20 mmHg
- •Open chest
- •Obvious severe hypovolemia ( LVEDA<5.5cm2/m2BSA)
结局指标
主要结局
Fluid responsiveness
时间窗: through the study, data collection during 1 year
Evaluation of fluid responsiveness, defined as 15% increase of cardiac output after reversible fluid challenge (using PLR - passive leg raise maneuver), by ultrasound doppler evaluation of superior vena caval blood flow respiratory variation.
次要结局
- Change of flow(through the study, data collection during 1 year)
- Respiratory variation of flow velocity(through the study, data collection during 1 year)
- Respiratory collapsibility(through the study, data collection during 1 year)
研究者
Martin Balik
A/Prof, MD, PhD
Charles University, Czech Republic