SHOCK US STUDY: Fluid Responsiveness in Sepsis Measured by Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid
研究概览
简要总结
The study aim is to examine point-of-care ultrasound findings, reliability, and ease of performance in association with fluid responsiveness for patients with severe sepsis and septic shock. The investigators propose a prospective observational research study of patients presenting to one of three Yale New Haven Hospital emergency departments, York Street Campus, St. Raphael's Campus, and Shoreline Medical Center who meet criteria for sepsis, severe sepsis or septic shock during their emergency department visit.
详细描述
After each 1 Liter fluid challenge of IV fluid each outcome measure will be repeated to determine if there is a change in ultrasound measures as patients undergo volume resuscitation.
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
- 是
入选标准
- •All patients age greater than 18 years who meet criteria of sepsis. Septic shock will be defined as those patients with severe sepsis and persistent hypotension (<90mmHg systolic blood pressure) despite a fluid challenge of at least 20cc/kg
- •Patients will only be considered eligible for enrollment if the treating physician plans to give at least 1-liter of crystalloid after initial US is performed
- •A number (approximately 50 patients) with no symptoms of sepsis will be enrolled to assess measurements in healthy patients. These patients will only have one ultrasound performed for each of the desired study measures.
排除标准
- •Patients unable to provide consent such as non-English speaking patients or patient/health care proxy unable to give consent
- •History of significant trauma
- •Incarcerated patients
- •Failure to complete fluid challenge
- •Pericardial disease or heart transplant. Patients with left bundle branch block, pulmonary hypertension, known systolic dysfunction (Ejection Fraction <40%), receiving vasopressors, known moderate or severe valvular dysfunction, and irregular heart rhythms will be enrolled but analyzed separately
结局指标
主要结局
Fluid responsiveness as defined by 15% increase in cardiac output in response to 1 liter of IV fluid
时间窗: participants will be followed for the duration of their emergency department stay, an expected average of 6 hours
Ultrasound Measurement: Carotid corrected flow time in relation to cardiac output to assess fluid responsiveness.
次要结局
- Fluid volume measurement as measured by ultrasound(participants will be followed for the duration of their emergency department stay, an expected average of 6 hours)
- Early (E') septal left ventricular filling velocity as measured by ultrasound(participants will be followed for the duration of their emergency department stay, an expected average of 6 hours)
- Late (A') septal left ventricular filling velocity as measured by ultrasound(participants will be followed for the duration of their emergency department stay, an expected average of 6 hours)
- Respirophasic carotid velocity (ΔVpeak) as measured by ultrasound in relation to cardiac output to assess fluid responsiveness.(participants will be followed for the duration of their emergency department stay, an expected average of 6 hours)
- Early (E) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.(participants will be followed for the duration of their emergency department stay, an expected average of 6 hours)
- Late (A) mitral inflow velocity in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.(participants will be followed for the duration of their emergency department stay, an expected average of 6 hours)
- Carotid velocity-time integral in relation to cardiac output to assess fluid responsiveness as measured by ultrasound.(participants will be followed for the duration of their emergency department stay, an expected average of 6 hours)