跳至主要内容
临床试验/NCT04680728
NCT04680728已完成不适用

Venous Congestion and Organ Dysfunction in Intensive Care: a Prospective, Multicenter, Observational Study to Evaluate Prevalence and Risk Factors.

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2020年10月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
185
试验地点
1
主要终点
the presence of venous congestion

研究概览

简要总结

Venous congestion, which is a phenomenon described in cardiology and post-operative cardiac surgery, is responsible for an increase in morbidity and mortality.

Indeed, it can lead to kidney failure, liver failure, prolonged ileus, scarring complications, and neurological disorders. Clinical and ultrasound indications have been described to diagnose this condition.

To date, this phenomenon is poorly known and not described in intensive care patients outside the cardiac context. However, intensive care patients can present the risk factors associated with the occurrence of congestion: acute cardiac failure, significant water-salt overload, and/or fluid distribution anomalies. Thus, observational studies have found an association between the input-output balance, the quantity of salt-water intake, the presence of right heart dysfunction and the occurrence of acute kidney failure, digestive disorders, hypoxemia and a prolonged stay in intensive care. The presence of a congestive condition is medically treatable since diuretic decongestion is associated with improved cardiac outcomes.

It is therefore necessary, in an intensive care context, to be able to define and diagnose this state of venous congestion, to study its prevalence, and to confirm the existence of a link with organ failure in order to pave the way to known adapted treatment options.

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

  • Patient who has expressed his or her non-opposition to the collection of data (or the health care proxy, or a close relative if the patien is unable to receive the information)
  • Patient admitted to intensive care for less than 24 hours.

排除标准

  • Person not affiliated to the national health insurance
  • Minor, protected major
  • Pregnant or breastfeeding women
  • Anechogenicity confirmed by the operator
  • Chronic atrial fibrillation
  • Mechanical cardiac assistance
  • Uncontrolled blood pressure (MAP < 65 mmHg)

研究组 & 干预措施

patient

Patient admitted to intensive care for less than 24 hours.

干预措施: collection of biological parameters (Other)

patient

Patient admitted to intensive care for less than 24 hours.

干预措施: collection of echographic parameters (Other)

patient

Patient admitted to intensive care for less than 24 hours.

干预措施: collection of clinical parameters (Other)

结局指标

主要结局

the presence of venous congestion

时间窗: From date of inclusion until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 28 day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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