Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Lactate clearance >20%
研究概览
简要总结
The purpose of this study is to determine whether the use of a 3-hour protocol utilizing non-invasive hemodynamic optimization treatment strategy results in better outcome and lower hospital costs in patients who present with severe bloodstream infections to the Emergency Department (ED).
详细描述
Severe sepsis is a syndrome where the body develops organ dysfunction secondary to uncontrolled inflammatory response to infection. Various resuscitation bundles have been formulated and practised to treat severe sepsis, such as early goal-directed therapy (EGDT). EGDT involves the insertion of invasive catheters in patients with severe sepsis or septic shock using serial measurements to guide therapy and achieve hemodynamic goals, such as mean arterial pressure (MAP), central venous pressure (CVP) and central venous oxygen saturation (ScvO2) by 6 hours. The drawbacks include the invasive nature of inserting these catheters with its complications and tedium to set up the equipment. A non-invasive approach using the Non-Invasive Cardiac Output Monitor (NICOM) and passive leg raising (PLR) maneuver to guide fluid and vasoactive agent therapy targeting fluid responsiveness and MAP may be able to achieve better outcome, measured by lactate clearance at 3 hours and at a lower hospitalization cost.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfillment of at least 2 systemic inflammatory response syndrome (SIRS) criteria
- •Suspected infection
- •Serum lactate ≥3mmol/L
排除标准
- •Age below 21 years
- •Known pregnancy
- •Prisoners
- •Do-not-attempt resuscitation status
- •Known severe aortic insufficiency or severe anatomic abnormalities of the thoracic aorta
- •Primary diagnosis of trauma, burns, active seizures, acute cerebral vascular accident, acute coronary syndrome, status asthmaticus, major cardiac arrhythmias, active gastrointestinal haemorrhage, seizure or drug overdose
- •Requirement for immediate surgery
- •Inability to do PLR (e.g. ankylosis of hip joint, severe sciatica)
- •Treating physician deems aggressive care unsuitable
- •Those unable to give informed consent and unable to comply with study requirements
结局指标
主要结局
Lactate clearance >20%
时间窗: 3 hours
Arterial lactate levels will be measured at 0 and 3 hours to determine degree of lactate clearance at 3 hours.
次要结局
- Total hospital cost(At discharge, death or 28 days, whichever occurs earlier)