Pilot Evaluation Using The Non-Invasive Cardiac Output Monitor (NICOM) for Goal-directed Fluid Resuscitation for Inpatients With Hypotension and/or Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 251
- 试验地点
- 1
- 主要终点
- ICU length of stay
研究概览
简要总结
The Non-Invasive Cardiac Output Monitor (NICOM) is a non-invasive monitor capable of measuring cardiac output (CO) and cardiac index (CI), and stroke volume (SV) and stroke volume index (SVI) based on heart rate. Conceptually NICOM is a technology that utilizes a dynamic response characteristic in assessing the need for fluid administration, whereby SVI is measured before and after a fluid challenge with more fluid given only if SVI increases significantly with administered fluid. Dynamic response technologies are intended to replace older, "static" measures such as central venous pressure (CVP) and pulmonary capillary wedge pressures (PCWP) which are single point measurements utilized to assess the need to administer fluid.
The aim is to pilot and evaluate the effectiveness of using The Non-Invasive Cardiac Output Monitor (NICOM) technology for goal-directed fluid resuscitation in adult inpatients with sepsis associated acute hypotension and/or evidence of septic shock (Lactate >= 4.0).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •All adult patients > 18 years of age
- •inpatients for >/= 6 hours
- •meeting criteria for sepsis as defined by hypotension related to sepsis (MAP < 65 or SBP < 90) or evidence of septic shock (Lactate ≥ 4.0).
排除标准
- •Patients who die within 24 hours of hospital admission
- •patients documented as "comfort cares" or enrolled in "general inpatient hospice" during the first 72 hours of hospitalization.
- •opted out of having their medical information used in research, as noted in the EHR.
研究组 & 干预措施
Non-Invasive Cardiac Output Monitor (NICOM)
adult inpatients with sepsis associated with acute hypotension and/or evidence of septic shock
干预措施: NICOM (Device)
结局指标
主要结局
ICU length of stay
时间窗: 18 months post-treatment
Hospital mortality
时间窗: 18 months post-treatment
Hospital length of stay
时间窗: 18 months post-treatment
次要结局
- Difference in positive fluid balance at 75 hours of ICU discharge(75 hours post treatment ( ICU discharge))
- Hours of vasopressor use(18 months post-treatment)
- change from baseline serum creatinine(18 months post-treatment)