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临床试验/NCT03622099
NCT03622099已完成不适用

Transthoracic Echocardiography Guided Small Volume Fluid Challenge as a Predictor of Fluid Responsiveness in Patients With Circulatory Failure: An Observational Study

Menoufia University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年9月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
1
主要终点
Aortic blood flow velocity Time Integral changes from the baseline

研究概览

简要总结

Assessment of intravascular volume status is difficult in critically ill patients. Evidence suggests that only 50% of hemodynamically unstable patients respond to a fluid challenge. Moreover, if cardiopulmonary function cannot compensate for the increase in preload, fluid loading may compromise microvascular perfusion and oxygen delivery and cause or aggravate peripheral and pulmonary edema. Inappropriate fluid expansion can increase morbidity and mortality thus making it important to accurately assess fluid responsiveness in critically ill patients. The volume responsiveness can be defined as a 15% increase in stroke volume (SV) or cardiac output (CO) after a 500-ml infusion. This study tested whether echocardiographic parameters can predict fluid responsiveness in critically ill patients following a low volume 100-ml crystalloid solution infusion over 1 minute.

详细描述

Fifty-four adult patients with circulatory failure were recruited for the study. As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, a 100 ml bolus of normal saline solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters were recorded1 minute after bolus administration. The remaining 400 ml of normal saline solution was infused at a constant rate over 10 minutes, and echocardiographic parameters were recorded again. The mean echocardiographic measurements over three consecutive respiratory cycles were recorded along with heart rate HR, systolic, diastolic and mean arterial pressures, central venous pressure, and Temperature also mechanical ventilation parameter (tidal volume, respiratory rate and PEEP) for each patient. Patients with an increase in CO after a 100 ml or total 500-ml infusion over 10 minutes (ΔCO500) of 15% or more were classified as responders (Rs) and those without an increase in CO was classified as non-responders

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute circulatory failure
  • Mechanically ventilated & sedated.(Tidal volume 6-8 ml/ kg, PEEP 5 mmHg, Richmond Agitation-Sedation Scale RASS (R) Score from zero to -3).
  • Systemic inflammatory response syndrome
  • Septic shock
  • Controlled massive hemorrhage

排除标准

  • Age of less than 18 years
  • Cardiomyopathy
  • Pulmonary edema
  • Morbid obesity
  • Pregnancy
  • Increased intracranial tension
  • Valvular heart disease
  • Myocardial ischemia or infarction before the study

研究组 & 干预措施

The study group

As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, A 100 ml bolus of Normal Saline Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response.

干预措施: Normal Saline Flush, 0.9% Injectable Solution (Drug)

结局指标

主要结局

Aortic blood flow velocity Time Integral changes from the baseline

时间窗: Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge

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次要结局

  • heart rate change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • systolic blood pressure change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • Diastolic blood pressure change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • Central venous pressure change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • stroke volume change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • cardiac output change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • Mean arterial blood pressure change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • Left ventricular end systolic diameter change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • Left ventricular end diastolic diameter change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)
  • Aortic root diameter change from the baseline(Baseline 10 minutes before start of fluid challenge and1 minute after fluid challenge)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Abd-Elazeem Abd-Elhameed Elbakry

Assistant professor

Menoufia University

研究点 (1)

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