Hemodynamic Effects of Cold Versus Warm Fluid Bolus Infusion in Healthy Volunteers: a Randomized Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Cardiac index 15 minutes
研究概览
简要总结
Fluid boluses are often administered with the aim of improving tissue perfusion in critically ill patients. It is unclear whether the temperature of the fluid has an impact on the hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid bolus with two different temperatures.
详细描述
A randomized, controlled, cross-over study in 21 healthy volunteers. The participants will receive a fluid bolus of 500 ml Ringer's Acetate at either 22°C or 38°C over 15 minutes in a randomized order. Non-invasive measures will be made of cardiac index, mean arterial pressure, systolic blood pressure, diastolic blood pressure, heart and pulse rate, saturation and temperature. Hemodynamic measure will be made using the Clearsight® system. Measurements will be made during 120 minutes. The second session will take place at least one day later, and the participant will then receive the other fluid temperature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Unblinded (unable to blind subjects)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Volunteers 18 years or older Previously healthy
排除标准
- •American Society of Anesthesiologists classification 2 or above.
- •Known pregnancy
研究组 & 干预措施
Body temperature fluid
500ml Ringers Acetate infused over 15 minutes warmed to 38°C
干预措施: Ringer's Acetate (warm) (Drug)
Room temperature fluid
500ml Ringers Acetate infused over 15 minutes cooled to 22°C
干预措施: Ringer's Acetate (cold) (Drug)
结局指标
主要结局
Cardiac index 15 minutes
时间窗: 15 minutes
Change in cardiac index at 15 minutes from start of infusion
次要结局
- Cardiac index 120 minutes(120 minutes)
- Blood pressure 120 minutes(120 minutes)
- Heart rate 120 minutes(120 minutes)
- Temperature 120 minutes(120 minutes)
研究者
Christer Svensen
Professor
Karolinska Institutet