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临床试验/NCT02135796
NCT02135796Unknown不适用

ICU Echocardiography in Resuscitation of Sepsis and Septic Shock

Intermountain Health Care, Inc.1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
700
试验地点
1
主要终点
Correlate echo findings and markers of resuscitation

研究概览

简要总结

BACKGROUND: Echocardiography can provide evaluation of right or left ventricular dysfunction and volume status during resuscitation of patients with sepsis and septic shock and guide intravenous vasopressor and fluid therapy. While there are numerous echocardiographic studies regarding cardiac function and volume status in patients with established shock, there are none that describe these during the early resuscitation of septic shock.

The study objective is to correlate echocardiographic findings with clinical parameters and net fluid balance measured during the early resuscitation of critically ill patients with sepsis and septic shock.

Aim 1) correlate echocardiographic findings of cardiac function with physiologic markers in the early hours of resuscitation

Aim 2) correlate cardiac function and fluid status with clinical outcomes

Aim 3) evaluate the change in cardiac function over time in patients with sepsis and septic shock

Aim 4) evaluate long term clinical outcomes for patients with sepsis and septic shock.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
13 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 13 years of age
  • SEPSIS PATIENTS:
  • Sepsis patients must have
  • Suspected or confirmed infection
  • Organ dysfunction as defined by a SOFA >= 2 above baseline (if no baseline data available, SOFA assumed to be 0)
  • SEPTIC SHOCK PATIENTS:
  • AFTER INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, Septic shock patients must have
  • Suspected or confirmed infection
  • Lactate > 2 mmol/L
  • Receiving vasopressors
  • Enrollment of patients should occur within 8 hours of meeting criteria for severe sepsis or septic shock if it is required that a research only TTE be performed in the 0-6 hours after ICU admission. If a clinical TTE is performed in this timeframe, patients may be enrolled up to 24 hours after ICU admission.

排除标准

  • 未提供

结局指标

主要结局

Correlate echo findings and markers of resuscitation

时间窗: Within 12 hours of Intensive Care Unit admission

Correlate echocardiographic findings of cardiac function with physiologic markers in the early hours of resuscitation. Specifically, cardiac markers will be analyzed in relation to cardiac function, including ejection fraction, strain, and diastolic function, and correlate these with several clinical parameters, including receipt of fluid, vasopressors, mechanical ventilation, and septic cardiomyopathy

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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