Study on the Effects of Cold and Room Temperature Ringer’s Lactate Solution on Blood Flow and Clotting in Healthy Adults

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What is this study about?

The study focuses on understanding how different temperatures of a fluid called Ringer’s lactate affect the body. Ringer’s lactate is a solution used in medical settings to provide essential minerals and fluids to the body. It contains substances like potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium lactate. The study will compare the effects of this solution when it is cooled to 10 degrees Celsius versus when it is at room temperature, which is 22 degrees Celsius.

The purpose of the study is to see how these different temperatures of Ringer’s lactate affect healthy adults, particularly looking at how it influences blood circulation and the body’s ability to stop bleeding, known as hemostasis. Participants will receive the solution through an intravenous infusion, which means it will be delivered directly into the bloodstream through a vein. The study will observe changes in blood pressure, heart rate, and other related factors to understand the body’s response to the fluid at different temperatures.

This research is designed as a randomized crossover trial, meaning participants will receive both temperature variations of the solution at different times. The main focus is to measure changes in mean arterial pressure, which is a type of blood pressure, 30 minutes after the infusion starts. Other observations will include how long it takes for blood pressure to return to normal, changes in body temperature, and other physiological responses. The study aims to provide insights into how temperature variations in medical fluids can impact the body’s functions.

1 joining the study

Upon joining the study, the participant will be informed about the trial’s purpose, which is to investigate the effects of **Ringer’s lactate solution** at different temperatures on the body’s response.

The participant will be required to confirm their age, which must be between 18 and 64 years, as part of the eligibility criteria.

2 initial assessment

Before the infusion begins, baseline measurements will be taken. These include blood pressure, heart rate, body temperature, and other vital signs.

Blood samples may be collected to assess biochemical parameters.

3 infusion of ringer's lactate

The participant will receive an **intravenous infusion** of **Ringer’s lactate solution**. This solution contains potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium lactate.

The infusion will be administered at two different temperatures: 10 degrees Celsius and 22 degrees Celsius, in separate sessions.

The primary focus is to observe the increase in mean arterial pressure (MAP) 30 minutes after the infusion starts.

4 monitoring during infusion

During the infusion, continuous monitoring of blood pressure, heart rate, and other vital signs will occur.

The participant’s response to the infusion, including any changes in temperature, blood pressure, and heart rate, will be recorded.

5 post-infusion assessment

After the infusion, the participant will be monitored to determine the time it takes for the mean arterial pressure to return to baseline values.

Additional measurements will be taken at 30 and 60 minutes post-infusion to assess changes in various physiological and biochemical parameters.

6 completion of trial session

Once all assessments are completed, the session will conclude.

The participant may be required to return for a second session to receive the infusion at the alternate temperature, as this is a crossover study.

Who Can Join the Study?

  • Age between 18 and 64 years old.
  • Both male and female participants are eligible.
  • Participants should be healthy adults, meaning they do not have any significant health issues.

Who Cannot Join the Study?

  • Individuals who are not considered healthy adults cannot participate. This means you should not have any ongoing health issues.
  • Participants must be within a specific age range. If you are too young or too old, you may not be eligible.
  • People who are part of a vulnerable population are not allowed to join. This includes groups who might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Odense University Hospital Odense Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Not recruiting
02.10.2023

Trial locations

Ringer’s Lactate Solution is a type of fluid that is often used in medical settings to help maintain the body’s fluid balance. It contains a mix of water and important salts, similar to the natural fluids in your body. In this trial, the solution is being tested at two different temperatures, 10 degrees Celsius and 22 degrees Celsius, to see how these temperatures affect blood circulation and the body’s ability to stop bleeding in healthy adults. The goal is to understand how the temperature of the solution might change its effects on the body when given through a vein. This information could help improve how fluids are used in medical treatments.

Hemodynamic Parameters – Hemodynamic parameters refer to the various measurements that assess the blood flow and pressure within the cardiovascular system. These parameters include mean arterial pressure, heart rate, cardiac output, and peripheral oxygen saturation, among others. Changes in these parameters can indicate how well the heart is pumping blood and how effectively the blood vessels are functioning. The progression of hemodynamic changes can be influenced by factors such as fluid volume, temperature, and the body’s physiological response to different conditions. Monitoring these parameters helps in understanding the body’s circulatory status and can guide medical interventions.

Trial ID:
2023-506018-35-00
Protocol code:
SVS.FAM.02
Trial Phase:
Human Pharmacology (Phase I) – Other

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