跳至主要内容
临床试验/NCT01680770
NCT01680770进行中(未招募)不适用

Use of Ultrasonography to Determine Fluid-responsiveness for Shock in a Population of Intensive Care Unit Patients

University of Chicago1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2010年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
124
试验地点
1
主要终点
Fluid Responder vs. Non-responder

研究概览

简要总结

The objective of our study is to determine the correlation of transthoracic ultrasonographic indices of fluid responsiveness to changes in direct measures of cardiac output and to compare them to other established predictors of fluid responsiveness such as central venous pressure variation, systolic arterial pressure variation and pulse pressure variation in a broad population of patients.

Hypothesis: There will be a significant difference in the inferior vena cava respiratory variation and subclavian vein respiratory variation between responders and non-responders to intravenous fluid challenge in a broad population of patients with shock.

详细描述

Shock is a common occurrence in the intensive care unit (ICU), and the management of this condition frequently requires the administration of intravenous fluids (IVF). Multiple studies have shown that only about 50% of these patients will respond to fluids. The ability to predict which patients will respond is an important tool for clinicians to treat shock while avoiding unnecessary fluid administration in those who are unlikely to respond. This is essential to avoid the adverse effects of fluid loading that can occur.

A number of studies have attempted to determine predictors of volume-responsiveness through various methods, including the use of ultrasonography performed by intensivists, anesthesiologists and emergency medicine physicians. The currently published studies establish predictors of fluid-responsiveness in their populations. However, there has been large variability in the study designs, making it difficult to compare different modalities.

The objective of our study is to determine the correlation of transthoracic ultrasonographic indices of fluid responsiveness to changes in direct measures of cardiac output and to compare them to other established predictors of fluid responsiveness such as central venous pressure variation, systolic arterial pressure variation and pulse pressure variation. Furthermore, we wish to include a broad range of patients with different types of shock in order to determine the generalized applicability of these indices. Additionally, reported success of intensivist-obtained echocardiographic images varies widely in the literature, but most studies do not report which views are most accessible. We plan to study prospectively which views are obtainable and correlate them to patient characteristics.

This would potentially establish echocardiography by an intensivist as a widely applicable, non-invasive, and easily accessible method for determining fluid-responsiveness in a patient with shock. Achievement of this goal would allow clinicians to quickly identify those patients that would respond to fluids and at the same time minimize the administration of fluids to those in whom it is unlikely to benefit.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (> 18 years old) admitted to the intensive care unit.
  • Decision by clinicians to give intravenous fluids for volume expansion.
  • Decision by clinicians to obtain central venous access.

排除标准

  • Patients with known chronic right heart failure syndromes.
  • Patients with terminal conditions in whom aggressive care will not be pursued.
  • Patients with a history of left bundle branch block.
  • Patients will not be excluded on the basis of sex, race, or ethnicity.

结局指标

主要结局

Fluid Responder vs. Non-responder

时间窗: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)

Patients will be divided into responder and non-responder groups based on an increase in cardiac output of greater than or equal to 15% as measured by thermodilution from a right heart catheter in response to a one liter normal saline fluid bolus.

次要结局

  • Possible views of echocardiogram(pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour))
  • Inferior vena cava diameter and respiratory variation(pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour))
  • subclavian vein diameter and respiratory variation(pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour))
  • pulse pressure variation(pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour))
  • central venous pressure (CVP) and CVP respiratory variation(pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour))
  • Concurrence with cardiologist interpretation(pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour))
  • pulmonary capillary wedge pressure (PCWP) and respiratory variations of PCWP(pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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