A Multi-center Randomized Comparison of a Minimally-invasive Cardiovascular Hemodynamic Optimization (MiCHO) Protocol Versus Early Goal-Directed Therapy (EGDT) in the Management of Septic Shock Patients Presenting to the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Mortality
研究概览
简要总结
Early intervention in the treatment of septic shock, including early goal-directed therapy (EGDT) in the first 6 hours of disease presentation, has been shown to significantly decrease mortality. However, this approach requires invasive hemodynamic monitoring, thus limiting its widespread application in the emergency department setting. A minimally invasive protocol utilizing esophageal Doppler monitoring (EDM) may be of benefit and practical if it is shown to result in similar outcome as EGDT.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients >= 18 years old
- •Source of infection
- •Two or more of systemic inflammatory response syndrome criteria
- •Systolic blood pressure < 90 mmHg after a fluid bolus OR lactate >= 4 mmol/L
- •A central line has been placed for CVP/ScvO2 monitoring
排除标准
- •Pregnancy
- •Acute stroke
- •Acute cardiogenic pulmonary edema
- •Status asthmaticus
- •Unstable cardiac dysrhythmia
- •Active hemorrhage
- •Acute seizure
- •Drug overdose
- •Requiring immediate surgery
- •Do-not-resuscitate status
研究组 & 干预措施
MiCHO
A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)
干预措施: Esophageal Doppler monitoring - CardioQ, Deltex Inc (Device)
EGDT
A 6-hour resuscitation protocol utilizing CVP/ScvO2
干预措施: Central line with CVP and continuous ScvO2 monitoring (Device)
结局指标
主要结局
Mortality
时间窗: hospital
In-hospital mortality
次要结局
未报告次要终点
研究者
H. Bryant Nguyen
Medical Doctor
Loma Linda University