跳至主要内容
临床试验/NCT03066375
NCT03066375已完成不适用

Diagnostic Accuracy of the Inferior Vena Cava Collapsibility to Predict Fluid Responsiveness in Spontaneously Breathing Patients With Sepsis, Acute Circulatory Failure, and Irregular Cardiac Rhythm

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2012年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
55
试验地点
1
主要终点
respiratory variations in inferior vena cava diameters with respect to the response to fluid resuscitation, assessed by the area under the ROC curve

研究概览

简要总结

Objectives: To investigate whether respiratory variations of inferior vena cava diameters (cIVC) predict fluid responsiveness in spontaneously breathing patients with septic acute circulatory failure and irregular heartbeats.

Design: Prospective, bicentric study, intensive care units.

Patients and measures: Spontaneously breathing patients with sepsis and clinical signs of acute circulatory failure are included. A positive response to fluid loading (FL) is defined as an increase of the stroke volume (SV) >10%. The investigators measured the minimum inspiratory and maximum expiratory diameters of the IVC (idIVC and edIVC) during standardized (st) and unstandardized (ns) breathing. The investigators calculated cIVCst and cIVCns before a 500ml-colloid FL.

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 of the intensive care units of the Lille university-hospital and of the Valencienne general hospital.
  • Age greater than or equal to
  • Patient insured
  • Spontaneous breathing without ventilatory support or intubation or tracheotomy.
  • Irregular cardiac rhythm
  • Prescription by the physician in charge of the patients of a 500 mL volume expansion in less than 30 minutes.
  • Patients with sepsis with at least one sign of acute circulatory failure:
  • Tachycardia with heart rate> 100/min
  • systolic blood pressure <90mmHg or a decrease >40mmHg in previously hypertense patient
  • Oliguria <0.5ml/kg/hour for at least one hour
  • skin mottling

排除标准

  • high-grade aortic insufficiency
  • transthoracic echogenicity unsuitable for measuring the stroke volume or inferior vena cava diameters
  • clinical signs of active exhalation
  • clinical or ultrasonographic evidence of pulmonary edema due to heart failure
  • pregnancy
  • abdominal compartment syndrome
  • regular cardiac rhythm

结局指标

主要结局

respiratory variations in inferior vena cava diameters with respect to the response to fluid resuscitation, assessed by the area under the ROC curve

时间窗: during 30 minutes of the volume expansion

次要结局

未报告次要终点

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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