Italian Group of Study on the Role of Oxygen Saturation as a Potential Surrogate Marker of Intradialytic Cardiovascular Instability
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
- 否
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
Antonio Santoro
Professor Antonio Santoro MD, Chief of Nephrology
IRCCS Azienda Ospedaliero-Universitaria di Bologna
