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临床试验/NCT02195830
NCT02195830Unknown不适用

Bedside Ultrasound of Inferior Vena Cava Collapsibility in Emergency Department Patients Presenting With Severe Sepsis and Septic Shock

Teesside University2 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
112
试验地点
2
主要终点
Mean baseline inferior vena cava collapsibility index

研究概览

简要总结

There is debate regarding the use of non invasive (ultrasound assessed) parameters of fluid volume status in patients with sepsis.

To establish the role of inferior vena cava ultrasound in guiding fluid resuscitation we first need to define the inferior vena cava collapsibility index in this population of patients.

The research question is: In adult patients with sepsis, severe sepsis and septic shock what is the mean baseline inferior vena cava collapsibility index (IVCCI) prior to fluid resuscitation.

详细描述

The study is an interventional cohort study using a convenience sample of adult patients in a university teaching hospital Emergency Department.

Eligible participants who consent to partake in the trial will have an ultrasound assessment of their inferior vena cava performed and the IVCCI will be calculated at enrolment.

Care will be provided in line with the published guidelines on sepsis management from the Surviving Sepsis Campaign and the College of Emergency Medicine.

A sample size calculation has been performed which indicates that 112 patient with severe sepsis or septic shock will need to be enrolled.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

入选标准

  • Adult patients
  • signs and symptoms of infection with 2 or more SIRS criteria (pulse rate >90/min, Temp > 38 Celsius < 36 Celsius, Respiratory rate > 20 breaths per minute, or white cell count >12 or <4 x 10^9/L)

排除标准

  • in relation to this episode of care: Prior cardio pulmonary resuscitation, acute myocardial infarction, trauma, pregnancy or patient requiring immediate surgery.
  • Patients who have received more than 20ml/Kg of IV fluid in the pre hospital environment
  • Patients with known tricuspid regurgitation, congestive heart failure or pulmonary hypertension
  • Patients receiving palliative terminal supportive care

结局指标

主要结局

Mean baseline inferior vena cava collapsibility index

时间窗: At enrollment

次要结局

未报告次要终点

研究者

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

Simon Richards

Programme Leader Medical Ultrasound

Teesside University

研究点 (2)

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