跳至主要内容
临床试验/NCT04436575
NCT04436575Unknown不适用

Interest of Clinical Ultrasound in Patients Consulting for Acute Gastrointestinal Bleeding in the Emergency Department: an Observational Monocentric Study

SUD Association pour le Développement de la Recherche et de lEnseignement1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Correlation of ultrasound parameters with the occurrence of adverse events

研究概览

简要总结

Acute Gastrointestinal (GI) Bleeding are a common chief complaint among Emergency Department. The mortality rate for Lower GI Bleeding is 3.9%. While the mortality rate can be as high as 10% for Upper GI Bleeding. Most existing scores take into account hemodynamic parameters such as systolic blood pressure or heart rate. Studies have shown that hemodynamic instability only develops late in the course of a bleed, as evidenced by a blood depletion of 30 to 40% of the total blood volume. Currently, few studies have examined the value of echocardiography in the management of patients presenting for Acute GI Bleeding in the Emergency Department. The main objective of this study is to show whether simple ultrasound parameters can, combined with clinico biological parameters, predict in an early manner the evolution of the patient presenting to the Emergency Department for Acute Gastrointestinal Bleeding.

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

  • Primary reason for emergency Department admission is acute gastrointestinal bleeding

排除标准

  • Pregnant or breastfeeding women
  • Persons not benefiting from a social security scheme
  • Persons deprived of liberty
  • Patient participates in another study
  • The patient is in a period of exclusion determined by a previous study.
  • The patient is under legal protection, guardianship or trusteeship.
  • Patient refuses to participate
  • It proves impossible to give informed information about the subject matter
  • The patient is not fluent in French.

结局指标

主要结局

Correlation of ultrasound parameters with the occurrence of adverse events

时间窗: 1 day

The primary outcome was to determine the correlation of echocardiography parameters to detect adverse events (AEs). Echocardiography parameters included signs of severe hypovolemia (end systolic left ventricular obliteration and/or complete inspiratory collapse of the inferior vena cava and/or E velocity \< 0.7 m/s). Adverse events were defined as blood transfusion, therapeutic intervention to control haemorrhage (endoscopic, radiologic or surgical hemostasis), rebleeding and in-hospital mortality.

次要结局

  • Other ultrasound parameters with the occurrence of adverse events(1 day)
  • Echocardiography and clinical scores(1 day)

研究者

发起方
SUD Association pour le Développement de la Recherche et de lEnseignement
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thibaut MARKARIAN

Principal Investigator

SUD Association pour le Développement de la Recherche et de lEnseignement

研究点 (1)

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