Rapid Infusion of Ringer's Lactate Solution at Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Increase in MAP at 15 minutes after infusion of the fluid bolus.
研究概览
简要总结
In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion criteria is; Pre-existing medical problems, Pregnancy (validated through a certified pregnancy test), Body mass index >35 kg/m2, Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.
Primary outcome is
- The increase in MAP at 15 minutes after infusion of the fluid bolus. Secondary outcome is
- Time until return of MAP to baseline value after infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-64
排除标准
- •Pre-existing medical problems
- •Pregnancy (validated through a certified pregnancy test)
- •Body mass index >35 kg/m2
- •Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
研究组 & 干预措施
Cold-Warm
Trial day 1: Participants receive Ringer's lactate cold (15°C, 59°F), Trial day 2: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F)
干预措施: Ringer's Lactate (Drug)
Warm-Cold
Trial day 1: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) Trial day 2: Participants receive Ringer's lactate cold (15°C, 59°F),
干预措施: Ringer's Lactate (Drug)
结局指标
主要结局
Increase in MAP at 15 minutes after infusion of the fluid bolus.
时间窗: 15 minutes
次要结局
- Time until return of MAP to baseline value after infusion.(2 hours)