Pharmacodynamic Analysis of the HaemOdynamic Effects of a Standard Fluid BolUS - the PHOEBUS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- To measure, during the administration of a fluid bolus in order to perform volume expansion, the volume of fluid which causes an increase in cardiac output of less than 15%.
研究概览
简要总结
When the flow of blood ejected by the heart drops significantly, that is to say when there is "shock", one of the first treatments undertaken is often volume expansion. This treatment consists of injecting a liquid intravenously, generally in the form of a bolus, that is to say a dose of solute administered all at once, of 250 to 500 mL of fluid over approximately 10 to 30 minutes. The injected fluid expands the blood volume and fills the heart pump, in order to increase the flow it ejects.
However, this treatment poses two problems. First, it is only inconsistently effective. It is possible that of the 250-500 mL of fluid administered in the standard way, only a part is effective, whereas, as the effectiveness decreases during the infusion, the rest does not increase cardiac output significantly.
However, the average part of the total volume that is ineffective on a large population of patients is not well known.
Second, the effects of volume expansion on cardiac output decrease rapidly after the end of administration. However, the average duration of effectiveness of a 250-500 mL fluid bolus, and the factors that influence this duration of effectiveness, are not well determined.
The main objective of this research is to measure, among the volume of a fluid bolus, which part does not significantly increase cardiac output. The secondary objective is to measure the average time of effectiveness after the end of the infusion and the factors that influence it.
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
- 否
入选标准
- •Age ≥18 years old
- •Hospitalisation in intensive care
- •Haemodynamic monitoring already in place with a pulse wave contour analysis-derived estimation of cardiac output (either calibrated or uncalibrated)
- •Decision taken by the clinicians in charge of the patient to perform volume expansion by intravenous infusion of a 6 mL/kg crystalloid bolus
排除标准
- •Pregnancy
- •Refusal to participate by relatives of the patient or the patient himself
- •Other therapeutic modification during volume expansion
结局指标
主要结局
To measure, during the administration of a fluid bolus in order to perform volume expansion, the volume of fluid which causes an increase in cardiac output of less than 15%.
时间窗: During the fluid bolus administration (<15min)
We will measure, among the volume administered (500mL), the proportion of infused volume which allowed an increase in cardiac output ≥15% compared to the baseline value. This baseline value will be defined by the average measured over the minute preceding the start of the fluid infusion
次要结局
- The maximum amplitude of the change induced by volume expansion in cardiac output, mean arterial pressure and central venous pressure(During the fluid bolus administration (<15min))
- The delay at which this maximum effect appears in terms of cardiac output, mean arterial pressure and central venous pressure(During the fluid bolus administration (<15min))
- The time following the end of the infusion from which the cardiac output becomes ≤5% of the baseline value(A period of 120 minutes following the fluid infusion)
- The factors that influence these pharmacokinetic variables will be determined(During the study period (during fluid administration and the period of 120 minutes following the infusion))
研究者
Christopher Lai
Doctor
Bicetre Hospital