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临床试验/NCT03285269
NCT03285269撤回不适用

Extension of the Rapid Ultrasound for Shock and Hypotension to Evaluate Volume Responsiveness

Kaiser Permanente0 个研究点开始时间: 2017年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Test Characteristics of the E-RUSH Protocol to Predict Fluid Responsiveness

研究概览

简要总结

The current study plants to create a patient registry of patients who present to the emergency department with signs and symptoms of shock and evaluate the ability of a multi-step cardiopulmonary ultrasound protocol to determine the need for fluid therapy.

详细描述

Background & Motivation: Non-traumatic shock accounts for millions of emergency department visits every year and is a significant burden on the health care system making rapid identification and treatment essential. For decades the Rapid Ultrasound in Shock and Hypotension (RUSH) exam has been employed to help determine the etiology of non-traumatic shock in the ED setting. The RUSH exam does not answer other critical questions such as the need for additional fluid resuscitation. The current study hypothesizes that by include a step-wise cardiopulmonary algorithm the RUSH exam can be extended (E-RUSH) to accurately determine the need for additional fluid therapy.

Study Design: Prospective Observational Study in two urban Emergency Departments with a combined annual census of >111,000.

Population: ED patients exhibiting signs of shock definied by a systolic blood pressure < 100 mmhg, MAP < 65, persistent tachycardia, mottled skin, or lactate >2mmol either at presentation or during ED stay will be included. Exclusion criteria will be inability to consent, external factors preventing ultrasound examination, age less than 18, pregnancy, incarceration, arrhythmia, cardiac arrest, or treating physician gestalt that the patient is not in shock.

Protocol: The E-RUSH protocol will include ultrasound exams of the IVC, heart and lungs as described in the RUSH protocol but will also evaluate cardiac output, IVC collapsibility, and presense of B-lines on lung ultrasound. At the time of ultrasound measuresments a bioreactance device will be applied. Bioreactance measurements and ultrasound measurement of cardiac output will be recorded pre and post a passive straight leg raise test. All charts will be reviewed by two experts who are blinded to ultrasound and bioractance measurements. When possible the protocol will be repeated 1-2 hours later or after initial interventions in order to provide trend data.

Data Analysis: Volume responsivness as assessed by the E-RUSH will be defined a priori using a step-wise flow diagram that combines IVC, lung and cardiac ejection fraction and output measurements (see research plan for details). Determination of volume responsiveness by the bioreactance device will be defined by manufacturer protocal. Determination of volume responsiveness by expert review will be by a standard abstraction form with agreement of both expert reviewers. Descriptive statistics will be performed to determine the test characteristics of the ultrasound protocol to predict volume responsiveness. Given the lack of a universally agreed upon gold standard for volume responsiveness, we will determine test characteristics for E-RUSH using the bioreactance device as a reference standard and using expert review as a second reference standard separately.

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

  • ED patients exhibiting signs of shock definied by a systolic blood pressure < 100 mmhg, MAP < 65, persistent tachycardia, mottled skin, or lactate >2mmol either at presentation or during ED stay will be included

排除标准

  • Exclusion criteria will be inability to consent, external factors preventing ultrasound examination, age less than 18, pregnancy, incarceration, arrhythmia, cardiac arrest, or treating physician gestalt that the patient is not in shock.

结局指标

主要结局

Test Characteristics of the E-RUSH Protocol to Predict Fluid Responsiveness

时间窗: 1 year

Will determine sensitivity and specificity of a step-wise cardiopulmonary approach to determine fluid responsivness.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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