Can the Venus 1000 Help Clinicians Treat Patients With Severe Sepsis or Acute Heart Failure? The CVP Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 30-day Readmission
研究概览
简要总结
The purpose of this study is to evaluate the impact that the Venus 1000 non-invasive CVP system has on the management of emergency department (ED) patients with fluid sensitive conditions.
详细描述
The ability to non-invasively, accurately, and continuously measure CVP to assess the preload status of ED patients could lead to its inclusion into existing protocols (similar to EGDT), or the development of novel protocols for the treatment of patients with fluid sensitive conditions. The majority of other non-invasive measures of preload, such as ultrasound of the inferior vena cava or the passive leg raise technique are not continuous measures and require some type of effort or skill on the part of the clinician. Continuous methods of assessing preload include CVP measurement through a central venous catheter, esophageal Doppler monitoring, and pulse contour analysis via arterial catheter monitoring, all of which involve invasive procedures.
The Venus CVP device is non-invasive and has continuous monitoring capabilities. The data acquired from this project will allow us to determine whether emergency physicians will, in practice, utilize the information provided by a non-invasive CVP monitoring device to assist in the management of their patients with severe sepsis or acute HF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
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
- •Age 18 years old or greater
- •English speaking
- •Clinical diagnosis of: 1) Severe Sepsis, or 2) Acute Heart Failure
排除标准
- •Traumatic injuries
- •Active bleeding
- •Pregnancy
- •Prisoners
- •Central venous catheter placement in the internal jugular or subclavian veins
- •Bilateral external jugular vein catheterizations
- •Concurrent enrollment into an interventional clinical trial that may affect subject treatment
结局指标
主要结局
30-day Readmission
时间窗: 30 days
次要结局
- Dose, timing and duration of all IV vasoactive medications(30 days)
- Duration of respiratory support(30 days)
- Length of stay in hospital(30 days)
- Number of repeat ED visits through 30 days post-discharge(30 days)
- Total amount of IV fluid administered over hospitalization(30 days)
- Rapid response activations(30 days)
- Mortality (in hospital, 7-day, 30-day)(30 days)