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临床试验/NCT03139123
NCT03139123已完成不适用

Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2017年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
1
主要终点
Presence of hypotensive episode by hemodynamic monitoring

研究概览

简要总结

Per-dialytic hypotension is common in Intensive Care Unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. To date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. New diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.

The aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in Intensive Care Unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.

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

  • Intensive Care Unit patients with acute kidney injury
  • under continuous renal replacement therapy initiated since less than 24 hours
  • under hemodynamic monitoring by the PiCCO® device.

排除标准

  • lower limb amputation
  • inferior vena cava compression
  • intracranial hypertension
  • age below 18 year
  • pregnancy
  • advance directives to withhold or withdraw life sustaining treatment,
  • lack of written informed consent by patient or next of kin
  • lack of affiliation to social security as required by French regulation
  • patient under a legal protective measure
  • previous inclusion in current study
  • inclusion in another research study

结局指标

主要结局

Presence of hypotensive episode by hemodynamic monitoring

时间窗: 7 days

An hypotensive episode is defined as mean arterial pressure \< 65 mm Hg and one of the following events : * Fluid administration * OR increase of vasopressor dose * OR decrease of fluid removal

Preload dependence identified by cardiac index greater than 10% during passive leg raising

时间窗: 7 days

The passive leg raising allows to identify the percentage of hypotensive episodes related to preload dependence. A change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases.

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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