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临床试验/NCT01759641
NCT01759641已完成不适用

Italian Group of Study on the Role of Oxygen Saturation as a Potential Surrogate Marker of Intradialytic Cardiovascular Instability

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
1
主要终点
SO2 short-term variability predictive power

研究概览

简要总结

The aim of the present work was to analyze the short-term variability of SO2 during hemodialysis in sessions with and without hypotension to correlate the SO2 variability to hemodynamic instability.

详细描述

During the last 40 years a lot has been achieved in dialysis regarding both monitors safety and membranes overall performances Anyway, intradialytic symptoms still remain a major concern for nephrologists: in particular, hypotension is the most frequent [1].

Intradialytic hemodynamic monitoring systems have been developed to have continuous surveillance of the main hemodynamic variables (heart rate, body temperature, blood pressure itself, cardiac output, ecc...).

In a second moment, the further evolution was towards the retroactive control systems, to force some of the variables involved in the genesis of the hemodynamic stability, along a pre-determined, ideal, trend. In this view, various bio-feedback mechanisms have been proposes along the years, for example, to tackle hypovolemia-related hypotension. Their scientific rationale is the control of either blood volume or directly natremia, in order to pilot plasma refilling towards the vascular compartment [2].

Despite the great achievements obtained, the forecasting of acute hypotension during hemodialysis still remains a complex problem, likely involving more than one variable.

SO2 can be considered an indirect expression of the hemodynamic stability. Moreover, in dialysis, it has always been regarded as a bio-compatibility marker for membranes [3]. Nowadays, SO2 changes during dialysis are easy to measure with a fully, non-invasive sensor assembled on the arterial line.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dialysis vintage > 6 months
  • Well functioning arterovenous fistula or central venous catheter
  • thrice weekly HD treatment schedule
  • Acute hypotensions in the last month before study start > 20% of sessions

排除标准

  • Mental illness
  • life expectancy < 6 months
  • any profiling and/or biofeedback strategies routinely prescribed

结局指标

主要结局

SO2 short-term variability predictive power

时间窗: 3 months

SO2 short term variability predictive power was assessed by means of common clinical tests indexes: sensitivity (number of sessions with effective hypotension correctly classified using SO2 standard deviation analysis) specificity (number of sessions without hypotension correctly classified using SO2 standard deviation analysis)

次要结局

  • Central venous catheters subgroup analysis(3 months)

研究者

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

Antonio Santoro

Professor Antonio Santoro MD, Chief of Nephrology

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (1)

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