NCT06622499已完成1 期
Rapid Intravenous Infusion of 10 and 22 Degrees Celsius Ringer's Lactate in Healthy Volunteers and Its Effects on Circulation and Hemostasis - a Randomized Crossover Trial
Esbjerg Hospital - University Hospital of Southern Denmark1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2023年11月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion
研究概览
简要总结
The aim of this study is to investigate the effect of respectively 10 and 22 degrees Celsius Ringer's lactate solution on the physiological response in healthy adults. In a single center crossover study the investigators will include and randomize 25 healthy volunteers to receive 1 liter of Ringer's lactate either cold (10°C, 50°F), or at room temperature (22°C, 71,6°F) with 100 ml/min. 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.
The main outcomes of this study are:
Primary:
• The increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion
Secondary:
- Time until return of MAP to baseline value after infusion.
- Changes in Visual Analog Scale (VAS) of discomfort during infusion
- Changes in temperature, blood pressure, heart rate, peripheral oxygen saturation cardiac index, cardiac output, total peripheral resistance index and stroke volume
- Changes in the intravascular volume status and the fluid responsiveness
- Changes in biochemical parameters at baseline, 30 and 60 minutes.
- Changes in Rotational thromboelastometry (ROTEM) analysis at baseline, 30 and 60 minutes
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 that are contraindicated for cold crystalloid infusions.
- •Pregnancy (validated through a certified urine pregnancy test)
- •Body mass index >35 kg/m2
- •Medication use, including over-the-counter anti-pyretics within 48 hours, with exception of allergy medication and contraceptives.
- •Any family history or predisposition of coagulopathies.
- •Any intake of inhibitors of 11β-Hydroxysteroid dehydrogenase the past 48 hours (products containing liquorice)
研究组 & 干预措施
Cold - Room temperature
Active Comparator
Trial day 1: Participants receive Ringer's lactate cold (10°C, 50°F), Trial day 2: Participants receive Ringer's lactate at room temperature (22°C, 71.6°F)
干预措施: Ringer's Lactate (Drug)
Room temperature - Cold
Active Comparator
Trial day 1: Participants receive Ringer's lactate at room temperature (22°C, 71.6°F), Trial day 2: Participants receive Ringer's lactate cold (10°C, 50°F)
干预措施: Ringer's Lactate (Drug)
结局指标
主要结局
Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion
时间窗: Trial day 1 & Trial day 2
次要结局
- Time until return of Mean Arterial Pressure (MAP) to baseline value after infusion(Trial day 1 & Trial day 2)
- Changes in Visual Analog Scale (VAS) of discomfort during infusion(Trial day 1 & Trial day 2)
- Changes in physiological parameter temperature measured in degrees Celcius(Trial day 1 & Trial day 2)
- Changes in physiological parameter blood pressure measured in millimeter of mercury (mmHg)(Trial day 1 & Trial day 2)
- Changes in physiological parameter peripheral oxygen saturation measured in percent (%)(Trial day 1 & Trial day 2)
- Changes in physiological parameter cardiac index measured in L/min/m2(Trial day 1 & Trial day 2)
- Changes in physiological parameter cardias output measured in L/min(Trial day 1 & Trial day 2)
- Changes in physiological parameter total peripheral resistance index measured in dyn·s/cm5(Trial day 1 & Trial day 2)
- Changes in physiological parameter stroke volume measured in mL(Trial day 1 & Trial day 2)
- Changes in physiological parameter intravascular volume status and fluid responsiveness measured in vena cava inferior maximum diameter and index via ultrasound(Trial day 1 & Trial day 2)
- Changes in physiological parameter of INR blood test measured in prothrombin time at baseline, after 30 minutes and after 60 minutes(Trial day 1 & Trial day 2)
- Changes in physiological parameter APTT blood test measured in seconds at baseline, after 30 minutes and after 60 minutes(Trial day 1 & Trial day 2)
- Changes in physiological parameter Fibrinogen blood test measured in µmol/L at baseline, after 30 minutes and after 60 minutes(Trial day 1 & Trial day 2)
- Changes in physiological parameter Platelet count blood test measured in 109/L at baseline, after 30 minutes and after 60 minutes(Trial day 1 & Trial day 2)
- Changes in physiological parameter Flowcytometry blood tests (CD63, CD62p, PAC-1) measured in % at baseline, after 30 minutes and after 60 minutes(Trial day 1 & Trial day 2)
- Changes in physiological parameter Rotational thromboelastometry (EXTEM, INTEM, FIBTEM analysis of Clotting time and maximum clot formation) measured in seconds and millimeters, respectively, at baseline, after 30 minutes and after 60 minutes(Trial day 1 & Trial day 2)
研究者
研究点 (1)
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