Time Course Evolution of Cardiac Output in Critically Ill Patients After a Fluid Expansion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 主要终点
- Change in cardiac output during fluid expansion
研究概览
简要总结
Fluid expansion is the first therapeutic option in patients presenting acute circulatory failure but the duration of its hemodynamic effects (persistency and time of maximal increase in cardiac output) is unknown.
This study is seeking to describe in critically ill patients, the time course evolution of cardiac output over a 2-hours period after a fluid expansion.
The objectives are:
- to identify patterns of fluid responsiveness
- to determine the time when the maximal increase in cardiac output occurs during and a after fluid expansion
- to compare patients' characteristics between patterns
Patients with acute circulatory failure will be recruited as soon as a fluid expansion will be decided by the physician in charge and the effects of fluid expansion on hemodynamic indices (cardiac output, arterial pressure) will be continuously recorded through a transpulmonary thermodilution device over a 2-hours period.
No changes in ventilatory settings nor vasopressors or sedatives will be allowed during the study.
Patients will be categorized into patterns according to the changes in cardiac output after fluid expansion and their characteristics will be compared.
详细描述
The study will be conducted in four medico-surgical ICUs in France between April 2016 and April 2018.
Since fluid challenge and invasive monitoring by thermodilution device is standard of care for septic shock management, the institutional review board waived patient consent. All patients and/or their next of kind will receive written information.
Eligible patients will have to present an acute circulatory failure for whom the physician in charge will decide to start a fluid expansion.
Hemodynamic variables will be obtained through transpulmonary thermodilution and pulse contour analysis (PICCO2 device, Pulsion Germany).
Fluid expansion will consist in the infusion of 500 ml of saline through a central venous catheter in a standardized 10-minutes period. The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute circulatory failure (infusion of norepinephrine)
- •invasive mechanical ventilation through an endotracheal tube
- •decision of fluid expansion
- •Non inclusion Criteria:
- •extracorporeal membranous oxygenation (ECMO)
- •active bleeding
- •continuous renal replacement therapy with weight loss
- •administration of diuretics within the past six hours
- •decision of therapeutic limitation,
- •age under eighteen years
- •Exclusion criteria:
- •hemodynamic instability after fluid expansion (mean arterial pressure < 65mmHg)
排除标准
- 未提供
研究组 & 干预措施
Patients
The patients will receive a 500 ml fluid expansion over a standardized 10 minutes period
干预措施: Saline Solution for Injection (Drug)
结局指标
主要结局
Change in cardiac output during fluid expansion
时间窗: 10 minutes
Difference between maximal cardiac output during fluid expansion and baseline
次要结局
- Change in cardiac output after fluid expansion(2 hours)