NCT02354742已完成不适用
Echocardiography-Guided Resuscitation in Severe Sepsis and Septic Shock Vs. Early Goal-Directed Therapy: Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms
研究概览
简要总结
Echocardiography (cardiac ultrasound) is being used more often in the critical care setting for management of severe infection (septic shock). Early studies show echocardiography to be useful in these patients, but at this time, there are no good clinical trials to justify its use.
Our study goals/objectives are as follows:
- To conduct an unblinded, two-group randomized controlled clinical trial to compare an echocardiography-guided resuscitation protocol with an Early Goal Directed Therapy (EGDT) protocol in patients with severe sepsis or septic shock.
- Demonstrate that a sepsis treatment protocol using transthoracic echocardiography and other non-invasive assessments of cardiac output will result in more rapid resolution of septic shock compared to invasive EGDT.
- Demonstrate patients receiving the non-invasive echocardiography protocol will receive less administration of intravenous fluid.
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
- •At least 18 years of age
- •Suspected infection
- •Two or more systemic inflammatory response syndrome (SIRS) criteria
- •White blood cell count less than 4,000 per mm3, greater than 12,000 per mm3, or differential with greater than 10% immature forms
- •Heart rate greater than 90 beats per minute
- •Respiratory rate greater than 20 breaths per minute or paCO2 less than 32 mmHg
- •Temperature less than 36°C or greater than 38°C
- •Evidence of refractory hypoperfusion attributed to sepsis (one or more of the following):
- •Systolic blood pressure less than 90 mmHg despite an intravenous fluid challenge of at least 30ml/kg (a portion of this may be albumin equivalent)
- •Blood lactate level at least 4 mmol/L.
- •Intention to place an arterial catheter.
- •Intention to place a central venous catheter.
- •Exclusion criteria:
- •Known pregnancy
- •Requirement for immediate surgery
- •Hypotension attributed to alternative cause
- •Treating physician deems the patient is moribund
- •Treating physician deems aggressive care is unsuitable
- •Contraindication to central venous catheterization or arterial catheterization
- •Advanced directives restricting implementation of the protocol
- •Significant pathology of the chest or abdominal wall that would make transthoracic echocardiography impossible (burns, chest trauma, etc.)
- •Children under the age of 18 will not be included in this study
排除标准
- 未提供
结局指标
主要结局
Comparison of Serial organ failure assessment (SOFA) scores in both treatment arms
时间窗: up to 72 hours
次要结局
- Inpatient mortality in both treatment arms(Up to ~7 days (Occurring during hospital stay).)
- Time to lactate clearance in both treatment arms(Up to ~7 days (Occurring during ICU hospital stay).)
- Number of ICU-Free days(28 days)
- Number of ventilator-free days(Up to ~7 days (Occurring during ICU hospital stay).)
- Daily and cumulative fluid balance in both treatment arms(Up to ~7 days (Occurring during ICU hospital stay).)
研究者
研究点 (2)
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